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Solid TumorPhase 2CBGJ398XUS04NCT02160041

BGJ398 for Patients With Tumors With FGFR Genetic Alterations

A Phase 2 study testing BGJ398 in people with Solid Tumor and Hematologic Malignancies, run by Novartis Pharmaceuticals at 56 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this signal seeking study was to determine whether treatment with BGJ398 demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or hematologic malignancies to warrant further study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Hematologic Malignancies
What is being tested?
BGJ398
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
56 sitesUnited States
Study dates
24 Jul 2014to 30 Apr 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Patient has a confirmed diagnosis of a select solid tumor (except with a primary diagnosis of Urothelial cell carcinoma, Cholangiocarcinoma, Endometrial cancer, and Glioblastoma multiforme) or hematologic malignancies and is in need of treatment because of progression or relapse.
  • Patient's tumor has been evaluated and pre-identified as having a tumor with a FGFR genetic alteration. The qualifying alteration must be assessed and reported by a CLIA-certified laboratory.
  • Patient must have received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
  • Patient must have progressive and measurable disease per RECIST 1.1. or other appropriate hematological response criteria.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Who cannot join

  • Patient has received prior treatment with BGJ398
  • Patients with Central Nervous System (CNS) metastasis or leptomeningeal carcinomatosis
  • Patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.
  • Patients with acute or chronic pancreatitis
  • Patients with impaired cardiac function or clinically significant cardiac diseases
  • History and/or current evidence of extensive tissue calcification
Show all 10Show fewer
  • Use of medications that increase serum levels of phosphorus and/or calcium
  • Current evidence of corneal or retinal disorder/keratopathy
  • History and/or current evidence of renal or endocrine alterations of calcium/phosphate homeostasis
  • Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

United States56 sites

  • New Mexico Cancer Center

    Albuquerque, New Mexico, 87109

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • St. Agnes Hospital St. Agnes Hospital (2)

    Baltimore, Maryland, 21229

  • Dartmouth Hitchcock Medical Center Dartmouth Hitchcock - Lebanon

    Bedford, New Hampshire, 03110

  • Bend Memorial Clinic Bend Mem. Clinic

    Bend, Oregon, 97701

  • Billings Clinic Billings Clinic (8)

    Billings, Montana, 59101

  • Alabama Oncology St. Vincent's Birmingham

    Birmingham, Alabama, 35211

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • University of N C at Chapel Hill Physician Office Building

    Chapel Hill, North Carolina, 27599-7600

  • Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology

    Chattanooga, Tennessee, 37404

  • Lurie Children's Hospital of Chicago Developmental Therapeutics

    Chicago, Illinois, 60611

  • Oncology Hematology Care Inc Oncology Hematology Care 2

    Cincinnati, Ohio, 45242

  • University Hospitals of Cleveland Seidman Cancer Center University Hospitals

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation Taussig Cancer Institute

    Cleveland, Ohio, 44195

  • Duke University Medical Center Seeley G. Mudd Bldg.

    Durham, North Carolina, 27710

  • Virginia Cancer Specialists Fairfax Northern Virginia

    Fairfax, Virginia, 22031

  • Southcoast Centers for Cancer Care

    Fairhaven, Massachusetts, 02719

  • Sanford Hematology Oncology

    Fargo, North Dakota, 58122

  • Florida Cancer Specialists Florida Cancer Specialists 36

    Fort Myers, Florida, 33901

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Cancer and Hematology Centers of West Michigan Dept. of Oncology

    Grand Rapids, Michigan, 49546

  • Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50)

    Greenwood Village, Colorado, 80304

  • Oncology Consultants Oncology Group

    Houston, Texas, 77024

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3)

    Houston, Texas, 77030

  • Indiana University Indiana Univ. - Purdue Univ.

    Indianapolis, Indiana, 46202

  • Research Medical Center Research Med Center (2)

    Kansas City, Missouri, 64132

  • University of Louisville / James Graham Brown Cancer Center SC

    Louisville, Kentucky, 40202

  • NorthWest Georgia Oncology Centers NW Georgia Oncology

    Marietta, Georgia, 30060

  • Texas Oncology

    McAllen, Texas, 78503

  • University of Miami Sylvester Comprehensive Cancer

    Miami, Florida, 33136

  • Minnesota Oncology Hematology, P.A. Minnesota Oncology Hem (27)

    Minneapolis, Minnesota, 55404

  • Intermountain Medical Center Intermountain Healthcare

    Murray, Utah, 84157

  • Tennessee Oncology Tennessee Oncology (3)

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • North County Oncology Medical Clinic Inc

    Oceanside, California, 92056

  • Northern Utah Cancer Associates Northern Utah Assoc (3)

    Ogden, Utah, 84403

  • Cancer Treatment Centers of America Eastern Regional Medical Center

    Philadelphia, Pennsylvania, 19124

  • University of Pittsburgh Cancer Institute Hillman Cancer Center (2)

    Pittsburgh, Pennsylvania, 15232

  • Northwest Cancer Specialists Northwest Cancer

    Portland, Oregon, 97210

  • Rhode Island Hospital Rhode Island Hosp. (2)

    Providence, Rhode Island, 02903

  • Harbin Clinic Medical Oncology Clin. Res.

    Rome, Georgia, 30165

  • University of Utah / Huntsman Cancer Institute SC-2

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists Utah Cancer Specialists (11)

    Salt Lake City, Utah, 84106

  • Cancer Therapy & Research Center UT Health Science Center Oncology Dept.

    San Antonio, Texas, 78229

  • San Francisco General Hospital San Francisco Gen Hosp (7)

    San Francisco, California, 94110

  • Sanford University of South Dakota Medical Center Sanford Health

    Sioux Falls, South Dakota, 57104

  • Northern Indiana Cancer Research Consortium No. Indiana Cancer Res.

    South Bend, Indiana, 46617

  • Northwest Medical Specialties NW Medical Specialties

    Tacoma, Washington, 98405

  • Texas Oncology Cancer Care & Research Center Texas Oncology

    Waco, Texas, 76712

  • Deke Slayton Cancer Center Deke Slayton Cancer Center (2)

    Webster, Texas, 77598

  • Shenandoah Oncology Shenandoah Oncology (5)

    Winchester, Virginia, 22601

  • Wake Forest Baptist Health Hem & Onc Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 6 - BGJ398 for Patients With Tumors With FGFR Genetic Alterations

The purpose of this signal seeking study was to determine whether treatment with BGJ398 demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or hematologic malignancies to warrant further study.

Being tested
BGJ398
Keywords
Solid tumor malignancy, hematologic malignancy, mutation, translocations, amplifications,, fusions, signature, FGFR, ligand, BGJ398
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGJ398Drug

    BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.

Study groups in NCT02160041
Study groupRoleWhat they receive
BGJ398ExperimentalBGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
Receives: Drug: BGJ398

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment

    Tumor Response: Overall response rate (ORR) and clinical benefit rate (CBR) for solid tumor (non-lymphoma) which excludes 3 TIO and 1 Lymphoma patients (hence 80 patients and not 84)

    Clinical benefit rate for patients with solid tumors were assessed using RECIST 1.1 and include responses of CR or PR or SD. For hematologic tumors other appropriate hematological response criteria may apply

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Measured: 16 weeks

Secondary outcomes (6)

  1. Overall Response (OR) or Partial Response (PR) or Greater

    The key secondary endpoint, OR, was determined by Investigator assessment for each tumor assessment and defined as responses of CR and PR per RECIST version 1.1.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Measured: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months

  2. Progression-Free Survival (PFS)

    Kaplan-Meier estimates of PFS timing, months

    Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause

    Measured: every 8 weeks until death, assessed up to 24 months

  3. Kaplan-Meier Estimates of PFS Rate, % (95% CI)

    Measured: Months 1, 2, 3, 4, 5, 6, 12, 18, 24

  4. Overall Survival (OS)

    Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause

    Measured: every 8 weeks until death, assessed up to 36 months

  5. Kaplan-Meier Estimates of Survival Rate, % (95% CI)

    Overall survival (OS) is the time from the date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact.

    Measured: months 3, 6, 9, 12, 24

  6. Number of Participants With 99 Day Minimum Duration of Response (DOR)

    The duration of response (PR or greater) applies only to patients whose best response was PR or greater. It is defined as the Ttime from the first documented response to the date first documented disease progression or relapse or death due to any cause

    Measured: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2014 (estimated)
  2. Study start24 Jul 2014
  3. Primary completion30 Apr 2018
  4. Study completion30 Apr 2018

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02160041
Sponsor's protocol ID
CBGJ398XUS04
Acronym
CBGJ398XUS04
Status last verified
May 2019
First submitted
6 Jun 2014
Last updated
18 Jun 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BGJ398 in people with Solid Tumor and Hematologic Malignancies, run by Novartis Pharmaceuticals at 56 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02160041.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.

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