Intracranial MeningiomaPhase 2NCT02523014
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
A Phase 2 study testing Vismodegib, FAK Inhibitor GSK2256098 and Capivasertib in people with Intracranial Meningioma and Recurrent Meningioma, run by Alliance for Clinical Trials in Oncology at 784 sites in United States.
Trial summary
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Meningioma, Recurrent Meningioma, NF2 Gene Mutation
- What is being tested?
- Vismodegib, FAK Inhibitor GSK2256098 and Capivasertib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 784 sitesUnited States
- Study dates
- 28 Sep 2015to 1 Jun 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Documentation of disease:
- Histologic documentation: histologically proven intracranial meningioma as documented by central pathology review
- Molecular documentation: Presence of SMO, PTCH1, NF2, CDKN2A, AKT1, PIK3CA, PTEN mutations, CDKN2A copy number loss, CDK4, CDK6, CCND1, CCND2, CCND3, or CCNE1 copy number gain in tumor sample as documented specifically by the central laboratory, regardless of whether prior genotype testing outside of the central laboratory was performed
- Progressive OR residual disease, as defined by the following:
- Residual measurable disease: residual measurable disease immediately after surgery without requirement for progression; for grade I disease, progression pre-operatively needs to be documented, with an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 25 months; for patients with SMO/PTCH1 mutations enrolling to receive vismodegib, the change can occur between scans separated by up to 25 months; residual measurable disease will be defined by bidimensionally measurable lesions with clearly defined margins by MRI scans, with a minimum diameter of 10 mm in both dimensions
- Progressive measurable disease: progression defined as an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 25 months
- Post radiation patients: patients with measurable and progressive meningioma who have received radiation are potentially eligible, but need to show evidence of progressive disease after completion of radiation; if the progressive meningioma lesion has been radiated, at least 24 weeks must have elapsed from completion of radiation to registration; if the progressive lesion is outside of the radiation field, then an interval of at least 2 weeks must have elapsed from completion of radiation to registration
- Measurable disease: measurable disease is defined by a bidimensionally measurable main lesion on MRI or computed tomography (CT) images (MRI preferred) with clearly defined margins and a minimum diameter of 10 mm in both dimensions; multifocal disease is allowed
- Prior treatment
- Prior medical therapy is allowed but not required
- No limit on number of prior therapies
- No chemotherapy, or other investigational agents within 28 days prior to registration
- No other concurrent investigational agents or other meningioma-directed therapy (chemotherapy, radiation) while on study; additionally, no cases of nitrosourea or mitomycin C within 6 weeks prior to registration
- For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval > 4 weeks must have elapsed from completion of radiation therapy to registration; if the progressive lesion is outside of the radiation field, then an interval of at least 2 weeks must have elapsed from completion of radiation to registration
- Steroid dosing stable for at least 4 days
- Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity from other agents with exception of alopecia and fatigue
- No craniotomy 28 days prior to and after registration
- Not pregnant and not nursing:
- A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- For patients with NF2/CDKN2A/AKT1/PIK3CA/PTEN mutation, CKDN2A copy number loss, or CDK4/CDK6/CCND1/CCND2/CCND3/CCNE1 copy number gain: Age >= 18 years
- For patients with SMO/PTCH1 mutation: Age >= 30 years
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Patient history:
- Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for 6 months
- No metastatic meningiomas (as defined by extracranial meningiomas outside of CNS) allowed; spinal meningiomas are allowed
- No history of allergic reactions attributed to compounds of similar or biologic composition to assigned study drug
- No known active hepatitis B or C
- No current Child Pugh class B or C liver disease
- No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease within 28 days of registration)
- No uncontrolled hypertension defined as blood pressure (BP) > 140/90
- No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 28 days prior to registration
- No major surgery within 28 days prior to registration for any patients with AKT1/PIK3CA/PTEN mutations receiving capivasertib
- For patients going on to receive capivasertib (i.e. enrolled after Update #08)
- Patients should not have any of the following cardiac criteria:
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram (EKG) (e.g., complete left bundle branch block, third degree heart block)
- Any factors that increase the risk of corrected QT (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, potential for Torsade de Pointes, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval
- Experience any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) class >= II
- Uncontrolled hypertension (systolic blood pressure [SBP] < 90 mmHg and/or diastolic blood pressure [DBP] < 50 mmHg)
- Cardiac ejection fraction outside institutional range of normal or < 50% (whichever is higher) as measured by echocardiogram (or multigated acquisition [MUGA] scan if an echocardiogram can't be performed or is inconclusive); left ventricular ejection fraction (LVEF) below lower limit of normal for site
- Patients should not have any of the following criteria:
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of registration
- Hemoglobin < 9 g/dL (< 5.59 mmol/L); note: any blood transfusion must be >= 14 days prior to the determination of a hemoglobin >= 9 g/dL (>= 5.59 mmol/L)
- Proteinuria 3+ on dipstick analysis or > 500 mg/24 hours
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of capivasertib
- History of hypersensitivity to active or inactive excipients of capivasertib or drugs with a similar chemical structure or class to capivasertib
- Current disease or condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
- Previous allogeneic bone marrow transplant
- Known immunodeficiency syndrome
- Concomitant medications (only regarding NF2/CDKN2A/CDK4/CDK6/CCND1/CCND2/CCND3/CCNE1/AKT1/PIK3CA/PTEN genetic alterations):
- Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study for patients with NF2 mutation enrolled to GSK2256098, as well as for patients with AKT1/PIK3CA/PTEN mutations enrolled to capivasertib
- For NF2 patients going on to receive GSK2256098 and for patients with AKT1/PIK3CA/PTEN mutations enrolled to capivasertib: concomitant treatment with strong CYP3A4 inducers or CYP2D6 substrates is not allowed; patients must discontinue the drug 14 days prior to registration
- For NF2 patients going on to receive abemaciclib: avoid concomitant use of CYP3A inducers and strong CYP3A inhibitors; use caution with coadministered moderate or weak CYP3A inhibitors
- Diabetic status:
- For patients with NF2 or SMO/PTCH1 mutations: No uncontrolled diabetes defined as a known diabetic with HBA1C > 7.5 OR fasting glucose > 140 mg/dL.
- For patients with AKT1/PIK3CA/PTEN mutations:
- Glycosylated hemoglobin (HbA1C) < 8.0% (63.9 mmol/mol)
- No type 1 diabetes mellitus
- No requirement for insulin for routine diabetic management and control
- No requirement for more than two oral hypoglycemic medications for routine diabetic management and control
- Patients with a pre-existing diagnosis of type 2 diabetes mellitus must have fasting glucose < 9.3 mmol/L (167mg/dL); fasting is defined as no caloric intake for at least 8 hours
- Patients without a pre-existing diagnosis of type 2 diabetes mellitus must have fasting glucose =< 7.0 mmol/L (126 mg/dL); fasting is defined as no caloric intake for at least 8 hours
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Creatinine OR =< 1.5 mg/dl x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance > 50 mL/min
- Urine protein:creatinine ratio (UPC) =< 45 mg/mmol
- Total bilirubin =< 1.5 x upper limit of normal (ULN); except in case of Gilbert's disease
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN
- Sodium, potassium, total calcium (corrected for serum albumin) \& phosphorus within normal limits per institutional guidelines
- QTcF < 450 msec (QT calculated using Fridericia formula)
- Mean resting heart rate (determined from EKG) 50-100 beats per minute (BMP) (must be obtained from 12-lead EKG defined by a triplicate EKG for patients assigned to the capivasertib arm; patients assigned to all other arms will require a single EKG
- No uncontrolled medical comorbidities per investigator discretion (e.g. interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or pre-existing Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)
- ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: Hemoglobin >= 8 g/dL
- Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; initial treatment must not begin earlier than the day after the erythrocyte transfusion
- ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: Prior Treatment
- Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] grade =< 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to registration; a washout period of at least 28 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy)
- Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy; a washout period of at least 28 days is required between end of radiotherapy and registration
- ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: No active bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]); screening is not required for enrollment in the absence of symptoms
- ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: No personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
Trial locations and contacts
784 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Priscilla Brastianos, MD contact
300 sites in 1 country
United States300 sites, 169 recruiting
- Suspended
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
- Recruiting
Riverwood Healthcare Center
Aitkin, Minnesota, 56431
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Benny J. Liem
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
MyMichigan Medical Center Gratiot
Alma, Michigan, 48801
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Elie G. Dib
- Recruiting
MyMichigan Medical Center Alpena
Alpena, Michigan, 49707
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Elie G. Dib
- Recruiting
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Active, not recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
- Active, not recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
- Suspended
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221
- Suspended
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
- Suspended
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
- Suspended
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
- Suspended
Anchorage Oncology Centre
Anchorage, Alaska, 99508
- Suspended
Katmai Oncology Group
Anchorage, Alaska, 99508
- Suspended
Providence Alaska Medical Center
Anchorage, Alaska, 99508
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Active, not recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
- Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
PCR Oncology
Arroyo Grande, California, 93420
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Active, not recruiting
AdventHealth Infusion Center Asheville
Asheville, North Carolina, 28803
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
Site Public Contact, 404-778-1868
Tomas Garzon-Muvdi
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Tomas Garzon-Muvdi
- Recruiting
Piedmont Hospital
Atlanta, Georgia, 30309
Site Public Contact, 404-425-7943, ORS@piedmont.org
Erin M. Dunbar
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Tomas Garzon-Muvdi
- Active, not recruiting
Sutter Auburn Faith Hospital
Auburn, California, 95602
- Active, not recruiting
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Denise M. Damek
- Recruiting
Rush-Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu
Vamsi K. Vasireddy
- Active, not recruiting
Dell Seton Medical Center at The University of Texas
Austin, Texas, 78701
- Active, not recruiting
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
- Recruiting
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Elie G. Dib
- Recruiting
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Site Public Contact, 888-446-3729
Jay W. Carlson
- Active, not recruiting
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
- Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Site Public Contact, 410-955-8804, jhcccro@jhmi.edu
Chetan Bettegowda
- Recruiting
CommonSpirit Saint Joseph Hospital - Bardstown
Bardstown, Kentucky, 40004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Isaac Melguizo-Gavilanes
- Active, not recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Essentia Health - Baxter Clinic
Baxter, Minnesota, 56425
Site Public Contact, 218-828-2880
Bret E. Friday
- Active, not recruiting
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
- Active, not recruiting
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
- Active, not recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
- Suspended
Overlake Medical Center
Bellevue, Washington, 98004
- Suspended
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
- Recruiting
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Suspended
Saint Charles Health System
Bend, Oregon, 97701
- Active, not recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
- Recruiting
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
Site Public Contact, 802-225-5400
Alissa A. Thomas
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Suspended
Saint Vincent Healthcare
Billings, Montana, 59101
- Active, not recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
- Active, not recruiting
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
Site Public Contact, 561-955-4800
Harold Richter
- Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Suspended
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
- Suspended
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
- Suspended
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628
- Active, not recruiting
McFarland Clinic - Boone
Boone, Iowa, 50036
- Active, not recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
- Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Site Public Contact, 877-726-5130
Nancy Wang
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Site Public Contact, 877-442-3324
Ugonma N. Chukwueke
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Cox Cancer Center Branson
Branson, Missouri, 65616
Site Public Contact, 417-269-4520
Jay W. Carlson
- Active, not recruiting
United Hospital Center
Bridgeport, West Virginia, 26330
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Lisa R. rogers
- Suspended
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
- Suspended
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
- Suspended
Highline Medical Center-Main Campus
Burien, Washington, 98166
- Active, not recruiting
Mills-Peninsula Medical Center
Burlingame, California, 94010
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Site Public Contact, 802-656-4101, rpo@uvm.edu
Alissa A. Thomas
- Recruiting
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Site Public Contact, 802-656-8990, rpo@uvm.edu
Alissa A. Thomas
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Isaac Melguizo-Gavilanes
- Suspended
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Active, not recruiting
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Suspended
Cambridge Medical Center
Cambridge, Minnesota, 55008
- Active, not recruiting
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
Site Public Contact, 888-446-3729
Jay W. Carlson
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Site Public Contact, 618-457-5200, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mercy San Juan Medical Center
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@commonspirit.org
Shahzad Siddique
- Suspended
Caro Cancer Center
Caro, Michigan, 48723
- Recruiting
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
SIH Cancer Institute
Carterville, Illinois, 62918
Site Public Contact, 618-985-3333, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Active, not recruiting
Eden Hospital Medical Center
Castro Valley, California, 94546
- Active, not recruiting
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
- Active, not recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Suspended
Saint Mary's Hospital
Centralia, Illinois, 62801
- Suspended
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
- Active, not recruiting
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
- Active, not recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
- Active, not recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu
David Schiff
- Recruiting
Minnesota Oncology Hematology PA-Chaska
Chaska, Minnesota, 55318
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Suspended
Memorial Hospital
Chattanooga, Tennessee, 37404
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Memorial Hospital of Laramie County
Cheyenne, Wyoming, 82001
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
John M. Schallenkamp
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Priya K. Bhasin
- Recruiting
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612
Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu
Joo Yeon Nam
- Active, not recruiting
University of Illinois
Chicago, Illinois, 60612
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Isaac Melguizo-Gavilanes
- Recruiting
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Site Public Contact, 877-779-7585, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Benjamin E. Lawler
- Suspended
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, 45202
- Suspended
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, 45211
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Rekha T. Chaudhary
- Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Oncology Hematology Care Inc-Anderson
Cincinnati, Ohio, 45230
- Active, not recruiting
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
- Recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45242
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, 45242
- Recruiting
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Natasha C. Edwin
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Recruiting
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Suspended
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
- Recruiting
Trinity Health IHA Medical Group - Primary Care - Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 248-858-6215, Emily.Crofts@Trinity-Health.org
Elie G. Dib
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Clement Pillainayagam
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Mark G. Malkin
- Recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Lisa R. rogers
- Recruiting
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Active, not recruiting
Big Horn Basin Cancer Center
Cody, Wyoming, 82414
- Recruiting
Billings Clinic-Cody
Cody, Wyoming, 82414
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Active, not recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
- Recruiting
Mount Carmel East Hospital
Columbus, Ohio, 43213
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Suspended
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
- Suspended
Riverside Methodist Hospital
Columbus, Ohio, 43214
- Suspended
Grant Medical Center
Columbus, Ohio, 43215
- Recruiting
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Mount Carmel Health Center West
Columbus, Ohio, 43222
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Suspended
Doctors Hospital
Columbus, Ohio, 43228
- Active, not recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Minnesota Oncology - Coon Rapids
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Suspended
Bay Area Hospital
Coos Bay, Oregon, 97420
- Recruiting
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
- Suspended
Greater Regional Medical Center
Creston, Iowa, 50801
- Suspended
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, 41017
- Recruiting
Essentia Health - Saint Joseph's Crosslake Clinic
Crosslake, Minnesota, 56442
Site Public Contact, 218-692-1010
Bret E. Friday
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Isaac Melguizo-Gavilanes
- Recruiting
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Site Public Contact, 414-302-2304, ncorp@aurora.org
Isaac Melguizo-Gavilanes
- Active, not recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
- Active, not recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Vamsi K. Vasireddy
- Active, not recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
- Active, not recruiting
Sutter Davis Hospital
Davis, California, 95616
- Suspended
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
- Active, not recruiting
Miami Valley Hospital
Dayton, Ohio, 45409
- Active, not recruiting
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
- Active, not recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
- Suspended
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
- Recruiting
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Lisa R. rogers
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
Site Public Contact, 305-243-2647
Macarena I. De La Fuente
- Suspended
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
- Suspended
Delaware Radiation Oncology
Delaware, Ohio, 43015
- Suspended
Grady Memorial Hospital
Delaware, Ohio, 43015
- Suspended
AdventHealth Porter
Denver, Colorado, 80210
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Lisa R. rogers
- Recruiting
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org
Elie G. Dib
- Recruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Active, not recruiting
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
- Recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com
Isaac Melguizo-Gavilanes
- Suspended
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Mercy Medical Center
Durango, Colorado, 81301
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Henry Ford River District Hospital
East China Township, Michigan, 48054
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Recruiting
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Suspended
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Benjamin E. Lawler
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Minnesota Oncology - Edina
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Suspended
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Vamsi K. Vasireddy
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Active, not recruiting
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
- Recruiting
Advocate Sherman Hospital
Elgin, Illinois, 60123
Site Public Contact, 847-429-2907
Isaac Melguizo-Gavilanes
- Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Essentia Health - Ely Clinic
Ely, Minnesota, 55731
Site Public Contact, 218-365-7900
Bret E. Friday
- Suspended
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
- Suspended
Saint Elizabeth Hospital
Enumclaw, Washington, 98022
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Providence Regional Cancer Partnership
Everett, Washington, 98201
- Recruiting
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
Site Public Contact, 907-458-3043, Veronica.Stevenson@foundationhealth.org
John M. Schallenkamp
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Adam L. Cohen
- Suspended
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, 45014
- Active, not recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
- Recruiting
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Active, not recruiting
Farmington Health Center
Farmington, Utah, 84025
- Suspended
Saint Francis Hospital
Federal Way, Washington, 98003
- Suspended
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, 56537
- Active, not recruiting
Armes Family Cancer Center
Findlay, Ohio, 45840
- Active, not recruiting
Blanchard Valley Hospital
Findlay, Ohio, 45840
- Active, not recruiting
Orion Cancer Care
Findlay, Ohio, 45840
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, 54937
Site Public Contact, 414-302-2304, ncorp@aurora.org
Isaac Melguizo-Gavilanes
- Active, not recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
- Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Site Public Contact, eileen.georgi@holy-cross.com
Elie G. Dib
- Suspended
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact, 800-378-9373
Jay W. Carlson
- Recruiting
Essentia Health - Fosston
Fosston, Minnesota, 56542
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Active, not recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
- Active, not recruiting
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
- Active, not recruiting
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee, 37067
- Active, not recruiting
Kaiser Permanente-Fremont
Fremont, California, 94538
- Active, not recruiting
Palo Alto Medical Foundation-Fremont
Fremont, California, 94538
- Active, not recruiting
Kaiser Permanente-Fresno
Fresno, California, 93720
- Active, not recruiting
Unity Hospital
Fridley, Minnesota, 55432
- Suspended
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
- Active, not recruiting
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
- Active, not recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Priya K. Bhasin
- Recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Site Public Contact, 414-302-2304, ncorp@aurora.org
Isaac Melguizo-Gavilanes
- Recruiting
MyMichigan Medical Center Gladwin
Gladwin, Michigan, 48624
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Elie G. Dib
- Recruiting
Glens Falls Hospital
Glens Falls, New York, 12801
Site Public Contact, 518-926-6700
Alissa A. Thomas
- Suspended
Mountain Blue Cancer Care Center
Golden, Colorado, 80401
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Isaac Melguizo-Gavilanes
- Recruiting
CHI Health Saint Francis
Grand Island, Nebraska, 68803
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803
- Active, not recruiting
Grand Valley Oncology
Grand Junction, Colorado, 81505
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Suspended
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
- Recruiting
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Site Public Contact, 414-302-2304, ncorp@aurora.org
Isaac Melguizo-Gavilanes
- Active, not recruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
- Suspended
East Carolina University
Greenville, North Carolina, 27834
- Active, not recruiting
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
- Active, not recruiting
Wayne Hospital
Greenville, Ohio, 45331
- Active, not recruiting
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, 29601
- Recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Active, not recruiting
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
- Recruiting
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Recruiting
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, karen.forman@ascension.org
Elie G. Dib
- Recruiting
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Recruiting
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Zangmeister Center Grove City
Grove City, Ohio, 43123
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Active, not recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Active, not recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
- Recruiting
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Nicholas A. Blondin
- Recruiting
Hi-Line Sletten Cancer Center
Havre, Montana, 59501
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
John M. Schallenkamp
- Recruiting
Tamarack Health Hayward Medical Center
Hayward, Wisconsin, 54843
Site Public Contact, 218-568-4416
Bret E. Friday
- Recruiting
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Site Public Contact, 708-799-9995
Isaac Melguizo-Gavilanes
- Active, not recruiting
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
- Recruiting
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
Benefis Helena Specialty Center
Helena, Montana, 59601
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Suspended
Saint Peter's Community Hospital
Helena, Montana, 59601
- Suspended
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052
- Recruiting
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052
- Recruiting
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
About this study
Official title: Phase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas With SMO/ AKT/ NF2/CDK Pathway Mutations
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the activity of a SMO inhibitor in patients with meningiomas harboring SMO and PTCH1 mutations as measured by 6-month progression free survival (PFS) and response rate.
II. To determine the activity of a FAK inhibitor in patients with meningiomas harboring NF2 mutations as measured by 6-month PFS and response rate.
III. To determine the activity of an AKT inhibitor in patients with meningiomas harboring AKT1/PIK3CA/PTEN mutations as measured by 6-month PFS and response rate.
IV. To determine the activity of a CDK inhibitor in patients with meningiomas harboring alterations in the CDK pathway or NF2 alterations as measured by 6-month PFS and response rate.
SECONDARY OBJECTIVES:
- To determine overall survival and progression-free survival of SMO, FAK, AKT and CDK inhibitors in patients with meningioma.
II. To determine adverse event rates of SMO, FAK, AKT and CDK inhibitors in patients with meningioma.
III. To determine the activity of SMO, FAK, AKT and CDK inhibitors as measured by response rate by central radiology review.
OUTLINE: Patients are assigned to 1 of 4 treatment arms based on their mutation status.
ARM A (SMO/PTCH1 mutation): Patients receive vismodegib orally (PO) once daily (QD). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL FEBRUARY 2018)
ARM B (NF2 mutation): Patients receive FAK inhibitor GSK2256098 PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL JULY 2017)
ARM C (AKT1, PIK3CA, or PTEN mutation): Patients receive capivasertib PO BID on days 1-4. Treatment repeats every 7 days for up to 1 cycle (28 days) in the absence of disease progression or unacceptable toxicity.
ARM D (CDK4, CDK6, CDKN2A, CCND1, CCND2, CCND3, CCNE1 alterations): Patients receive abemaciclib PO every 12 hours (Q12H). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for a maximum of 5 years from registration.
- Being tested
- Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, Abemaciclib
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VismodegibDrug
Also called GDC-0449
Given PO
FAK Inhibitor GSK2256098Drug
Given PO
CapivasertibDrug
Also called AZD5363
Given PO
AbemaciclibDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm A (vismodegib) | Experimental | Patients receive vismodegib PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL FEBRUARY 2018) Receives: Drug: Vismodegib |
| Arm B (FAK inhibitor GSK2256098) | Experimental | Patients receive FAK inhibitor GSK2256098 PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL JULY 2017) Receives: Drug: FAK Inhibitor GSK2256098 |
| Arm C (capivasertib) | Experimental | Patients receive capivasertib PO BID on days 1-4. Treatment repeats every 7 days for up to 1 cycle (28 days) in the absence of disease progression or unacceptable toxicity. Receives: Drug: Capivasertib |
| Arm D (abemaciclib) | Experimental | Patients receive abemaciclib PO Q12H. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Point estimates and 95% binomial confidence intervals will be generated for the six month PFS rate within each cohort of each treatment arm. Kaplan-Meier curves will be generated for PFS for each cohort within each treatment arm.
Measured: At 6 months
Response rate defined as a confirmed complete response (CR) or partial response (PR)
Point estimates will be generated for response rates within each treatment arm with corresponding 95% binomial confidence intervals.
Measured: Up to 2 years
Secondary outcomes (2)
Overall survival (OS)
OS will be summarized for each cohort within each treatment group with Kaplan-Meier curves and estimates.
Measured: Up to 2 years
Incidence of adverse events according to National Cancer Institute CTCAE version 4.0
Adverse events (AEs) will be summarized for each treatment group. They will be summarized as the number and frequency of each event. In addition the AEs will be summarized as the number and frequency of patients who experience any AE, AEs of grade 3+, and AEs of grade 4+.
Measured: Up to 4 weeks after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study start28 Sep 2015
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial MeningiomaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), GlaxoSmithKline, Genentech, Inc., Brain Science Foundation
- Responsible party
- Sponsor
- Investigators
- Priscilla Brastianos, MD, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523014
- Sponsor's protocol ID
- A071401
- Other IDs
- NCI-2015-00546
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2015
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Brastianos PK, Dooley K, Geyer S, Gerstner ER, Kaufmann TJ, Iafrate AJ, Martinez-Lage M, Milhem M, Welch MR, Kaley TJ, Drappatz J, Chan A, Kumthekar P, Matsuoka CK, Strowd RE, Cohen AL, Jaeckle K, Robell L, Magge RS, Nam JY, Blondin N, Shaikh N, Rabinowitz I, Thomas AA, Piccioni DE, Brown P, Kaluziak S, Codd E, Cahill DP, Santagata S, Barker FG 2nd, Galanis E. Abemaciclib in meningiomas with somatic NF2 or CDK pathway alterations: the phase 2 Alliance A071401 trial. Nat Med. 2026 Feb;32(2):717-724. doi: 10.1038/s41591-025-04141-4. Epub 2026 Jan 16.
PubMed 41545592Brastianos PK, Twohy EL, Gerstner ER, Kaufmann TJ, Iafrate AJ, Lennerz J, Jeyapalan S, Piccioni DE, Monga V, Fadul CE, Schiff D, Taylor JW, Chowdhary SA, Bettegowda C, Ansstas G, De La Fuente M, Anderson MD, Shonka N, Damek D, Carrillo J, Kunschner-Ronan LJ, Chaudhary R, Jaeckle KA, Senecal FM, Kaley T, Morrison T, Thomas AA, Welch MR, Iwamoto F, Cachia D, Cohen AL, Vora S, Knopp M, Dunn IF, Kumthekar P, Sarkaria J, Geyer S, Carrero XW, Martinez-Lage M, Cahill DP, Brown PD, Giannini C, Santagata S, Barker FG 2nd, Galanis E. Alliance A071401: Phase II Trial of Focal Adhesion Kinase Inhibition in Meningiomas With Somatic NF2 Mutations. J Clin Oncol. 2023 Jan 20;41(3):618-628. doi: 10.1200/JCO.21.02371. Epub 2022 Oct 26.
PubMed 36288512