AzTrials
AzTrials

Renal Cell CarcinomaPhase 1/2NCT01034631

BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma

A Phase 1/2 study testing Everolimus and BNC105P in people with Renal Cell Carcinoma, run by Hoosier Cancer Research Network at 108 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Everolimus and BNC105P
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
108 sitesin 3 countries
Study dates
Jan 2010to Dec 2016
Phase
Phase 1/2
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

  • Histological or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma).
  • Metastatic or locally advanced unresectable RCC. NOTE: Prior nephrectomy is not mandatory.
  • Progressive disease after 1-2 prior VEGF-directed tyrosine kinase inhibitors (TKIs).
  • Measurable disease according to RECIST and obtained by imaging within 30 days prior to registration for protocol therapy.
  • Written informed consent and HIPAA authorization for release of personal health information.
  • Age > 18 years at the time of consent.
  • Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation.
  • Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy.

Who cannot join

  • No active brain metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis within 30 days prior to registration on protocol therapy. NOTE: A patient with prior brain metastasis are eligible if they have completed their radiation treatment for brain metastasis ≥30 days prior to registration for protocol therapy, are off steroids, and are asymptomatic.
  • No other currently active malignancy.
  • No treatment with any investigational agent within 14 days prior to registration for protocol therapy. NOTE: If treated with investigational agent within 14 days prior to registration, AE must be resolved back to baseline.
  • Prior cancer treatment must be completed at least 14 days prior to registration for protocol therapy and the patient must have recovered from the acute toxic effects of the regimen. With the exception of Bevacizumab treatment, which must be completed 30 days prior to registration for protocol therapy.
  • Prior radiation therapy to < 25% of the bone marrow [see bone marrow radiation chart in the study procedure manual (SPM)] allowed if completed within 30 days prior to registration for protocol therapy.
  • Corrected QT interval (QTc) ≤ 450 msec at least 7 days prior to registration for protocol therapy.
Show all 14Show fewer
  • No clinically significant infections as judged by the treating investigator.
  • No liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
  • No collecting duct, medullary or sarcomatoid histology.
  • No prior treatment with temsirolimus or everolimus in the phase II component of the study. NOTE: Prior treatment with these agents is permitted in the phase I component of the study.
  • No use of full dose, therapeutic anti-coagulation with warfarin or related anti-coagulants or unfractionated or low molecular weight heparins.
  • No uncontrolled hypertension (BP >150/100mmHg despite full doses of 1 anti-hypertensive medication).
  • No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of registration for protocol therapy.
  • No grade 2 or greater peripheral neuropathy.

Trial locations and contacts

108 sites in 3 countries.

108 sites in 3 countries

United States94 sites

  • New York Oncology Hematology, PC

    Albany, New York, 12208

  • Presbyterian Medical Group

    Albuquerque, New Mexico, 87110

  • University of New Mexico Cancer Center: Albuquerque

    Albuquerque, New Mexico, 87131

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • Texas Oncology: Austin North

    Austin, Texas, 78758

  • Medical Oncology LLC

    Baton Rouge, Louisiana, 70809

  • Texas Oncology: Bedford

    Bedford, Texas, 76022

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Bozeman Deaconness Cancer Center

    Bozeman, Montana, 59715

  • Harrison HealthPartners Bremerton Hematology & Oncology

    Bremerton, Washington, 98310

  • Cancer Care Centers of Florida: Brooksville

    Brooksville, Florida, 34613

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Health System: Roy and Patricia Disney Family Cancer Center

    Burbank, California, 91505

  • MUSC Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Northwestern University, Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois, 60611

  • Compassionate Cancer Care Medical Group, Inc.

    Corona, California, 92879

  • Compassionate Cancer Care Medical Group

    Corona, California, 92879

  • Hematology and Oncology Associates of Rhode Island

    Cranston, Rhode Island, 02920

  • Texas Oncology, PA

    Dallas, Texas, 75246

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Centura Health Research Center

    Denver, Colorado, 80210

  • City of Hope

    Duarte, California, 91010

  • Dublin Hematology & Oncology Care

    Dublin, Georgia, 31021

  • Trinitas Regional Medical Center

    Elizabeth, New Jersey, 07202

  • Deaconess Clinic

    Evansville, Indiana, 47713

  • Broward Oncology Associates

    Fort Lauderdale, Florida, 33308

  • Fort Wayne Oncology & Hematology, Inc

    Fort Wayne, Indiana, 46815

  • Texas Oncology: Fort Worth

    Fort Worth, Texas, 76104

  • Robert A. Moss, M.D., FACP, Inc.

    Fountain Valley, California, 92708

  • California Cancer Associates for Research and Excellence

    Fresno, California, 93720

  • University of Florida, Shands Cancer Center

    Gainesville, Florida, 32610

  • Medical & Surgical Specialists, LLC

    Galesburg, Illinois, 61401

  • The Jones Clinic, PC

    Germantown, Tennessee, 38138

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17235

  • Western Oncology & Hematology

    Golden, Colorado, 80401

  • IU Health Goshen

    Goshen, Indiana, 46527

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49546

  • Sletten Cancer Specialists

    Great Falls, Montana, 59405

  • Marin Specialty Care

    Greenbrae, California, 94904

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

  • South Carolina Cancer Specialists

    Hilton Head Island, South Carolina, 29926

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Texas Oncology: Houston Memorial City

    Houston, Texas, 77024

  • Methodist Hospital Research Institute

    Houston, Texas, 77030

  • Houston Cancer Center

    Houston, Texas, 77055

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • IU Health Central Indiana Cancer Centers

    Indianapolis, Indiana, 46219

  • Community Regional Cancer Center

    Indianapolis, Indiana, 46256

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Cascade Cancer Center

    Kirkland, Washington, 98034

  • Horizon Oncology Research

    Lafayette, Indiana, 47905

  • NYU Langone Arena Oncology

    Lake Success, New York, 11042

  • Good Samaritan Hospital

    Los Angeles, California, 90017

  • UCLA Med - Hematology & Oncology

    Los Angeles, California, 90095

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410

  • Lynchburg Hematology Oncology Clinic, Inc.

    Lynchburg, Virginia, 24501

  • Dartmouth-Hitchcock Medical Center

    Manchester, New Hampshire, 03102

  • Metairie Oncologists

    Metairie, Louisiana, 70006

  • Advanced Pharma CR, LLC

    Miami, Florida, 33136

  • Signal Point Clinical Research Center

    Middletown, Ohio, 45042

  • University of Wisconsin, Clinical Cancer Center

    Milwaukee, Wisconsin, 53226

  • IU Health at Ball Memorial Hospital Cancer Center

    Muncie, Indiana, 47303

  • Monroe Medical Associates

    Munster, Indiana, 46321

  • Northwest Alabama Cancer Center

    Muscle Shoals, Alabama, 35661

  • Cancer Care Centers of Florida

    New Port Richey, Florida, 34652

  • Tisch Cancer Institute at Mount Sinai Medical Center

    New York, New York, 10029

  • Oncology Hematology Associates of SW Indiana

    Newburgh, Indiana, 47630

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960

  • Ocala Cancer Institute

    Ocala, Florida, 34471

  • Mercy Physicians Of Oklahoma

    Oklahoma City, Oklahoma, 73120

  • Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Purchase Cancer Group

    Paducah, Kentucky, 42001

  • First Health of the Carolinas

    Pinehurst, North Carolina, 28374

  • Allegheny Cancer Center

    Pittsburgh, Pennsylvania, 15212

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Compassionate Cancer Care Medical Group

    Riverside, California, 92501

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Cancer Care Centers of Brevard

    Rockledge, Florida, 32955

  • CTRC at The UT Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Group Health Medical Centers

    Seattle, Washington, 98109

  • University of Washington, Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Siouxland Hematology Oncology Associates, LLP, Nylen Cancer Center

    Sioux City, Iowa, 51101

  • Edward H. Kaplan, M.D., & Associates

    Skokie, Illinois, 60076

  • Somerset Hematology Oncology Associates

    Somerville, New Jersey, 08876

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • Rockwood Clinic

    Spokane, Washington, 99204

  • Willamette Valley Cancer Institute

    Springfield, Oregon, 97477

  • Mount Nittany Medical Center

    State College, Pennsylvania, 16803

  • Berks Hematology Oncology Associates

    West Reading, Pennsylvania, 19611

  • American Institute of Research

    Whittier, California, 90603

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Lawrence M. Stallings, M.D.

    Wooster, Ohio, 44691

  • Metro Health Cancer Care

    Wyoming, Michigan, 49519

Other trials in United States

Australia13 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital: Sydney Cancer Centre

    Camperdown, New South Wales, 2050

  • Peninsula Oncology Centre

    Frankston, Victoria, 3199

  • Gallipoli Medical Research Foundation: Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • Ashford Cancer Centre

    Kurralta Park, South Australia, 5037

  • Gallipoli Medical Research Foundation: Launceston General Hospital

    Launceston, Tasmania, 7250

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Sydney Adventist Hospital Ltd.

    Wahroonga, New South Wales, 2076

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4201

Other trials in Australia

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

About this study

Official title: Phase I/II Study of BNC105P in Combination With Everolimus or Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors

The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.

Read the detailed description

OUTLINE: This is a multi-center study.

Phase I: Patients will be accrued in the classic 3 patients per dose per cohort design, 21-day cycle

  • Dose Level 1 Everolimus 10 mg BNC105P 4.2 mg/m2
  • Dose Level 2 Everolimus 10 mg BNC105P 8.4 mg/m2
  • Dose Level 3 Everolimus 10 mg BNC105P 12.6 mg/m2
  • Dose Level 4 Everolimus 10 mg BNC105P 16 mg/m2

Phase II: Patients will be randomized 1:1 to Arm A or Arm B

Combination Arm A: Everolimus 10 mg + BNC105P MTD (from Phase 1 study) 21 day cycle

Sequential Arm B: Everolimus 10 mg 21 day cycle

  • Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.

Karnofsky Performance Score (KPS) ≥70 within 7 days prior to registration for protocol therapy.

Life Expectancy: Not specified

Hematopoietic:

  • White blood cell count (WBC) > 3.5 K/mm3
  • Hemoglobin (Hgb) > 8.5 g/dL
  • Platelets > 100 K/mm3
  • Absolute neutrophil count (ANC) > 1.5 K/mm3

Hepatic:

  • Total Bilirubin < 1.25 x ULN
  • Aminotransferase (AST and ALT) < 2.5 x ULN

Renal:

  • Serum Creatinine < 2.5 x ULN (upper limit normal)

Cardiovascular:

  • No significant cardiovascular events within 6 months (CVA, CAD, peripheral arterial obstruction, arrhythmias, cardiac dysfunction) of registration for protocol therapy
  • No history of clinical CHF or LVEF <50% by Echo (or MUGA) within 30 days prior to registration for protocol therapy.
Being tested
Everolimus, BNC105P
Keywords
Metastatic Kidney Cancer, BNC105P
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

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

  • EverolimusDrug

    Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals

  • BNC105PDrug

    BNC105P, up to 16 mg/m^2

Study groups in NCT01034631
Study groupRoleWhat they receive
Combination Arm A: Everolimus + BNC105PActive comparatorCombination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle
Receives: Drug: Everolimus; Drug: BNC105P
Sequential Arm B:Everolimus followed by BNC105P MonotherapyActive comparatorSequential Arm B: Everolimus 10 mg, 21 day cycle Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Receives: Drug: Everolimus; Drug: BNC105P

What is being measured

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

  1. Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.

    Phase I

    Measured: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months

  2. Phase I: Toxicities of BNC105P in Combination With Everolimus.

    Determine the toxicities of BNC105P in combination with everolimus. Drug-related treatment emergent adverse events by CTCAE grade 2 or greater are reported

    Measured: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months

  3. Phase II: 6-month Progression Free Survival (PFS) With the Addition of BNC105P to Everolimus.

    Improvement in 6-month PFS with the addition of BNC105P to everolimus. Progression is defined using RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

    Measured: 6 months

Secondary outcomes (7)

  1. Phase I: Response Rate of BNC105P in Combination With Everolimus.

    Number of objective responses per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

    Measured: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months

  2. Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus.

    Determine the PK Profile for BN105P in combination with everolimus by calculating the geometric mean half-life of BNC105P

    Measured: 12 months

  3. Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone

    Objective response is defined as a confirmed CR or PR per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

    Measured: 12 months

  4. Phase II: Progression Free Survival (PFS) With BNC105P Alone in Patients After Progressing on Everolimus.

    Median time to progression for arm P participants who crossed over to BNC105P monotherapy after progression. Progression is defined per RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

    Measured: 12 months

  5. Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen.

    Determine adverse events of everolimus and BNC105P when administered as a combination or sequential regimen. Total number of serious and non-serious adverse events for Arm A and Arm B are summarized. Complete adverse event information is supplied in the Adverse Events reporting section.

    Measured: 12 months

  6. Phase II: Overall Survival

    Determine overall survival probability, up to a maximum of 5 years from registration for protocol therapy.

    Measured: 60 months

  7. Exploratory Objective: Correlation of PFS With Biomarkers

    Exploratory analysis of serum biomarkers were undertaken to generate a potential signature for response. The correlation with 6 month progression free survival P value for four plasma biomarkers is reported.

    Measured: 6 months

Timeline

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

  1. First posted17 Dec 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2016
  4. Study completionDec 2016

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01034631
Sponsor's protocol ID
HOG GU09-145
Status last verified
Apr 2017
First submitted
15 Dec 2009
Last updated
11 Jul 2022
Data monitoring committee
Yes

Publications

  • Thomas E. Hutson, Long H. Dang, Richard C. Lauer, Alexander Starodub, Ralph J. Hauke, Matt D. Galsky, Kathryn A. Bylow, Theodore Logan, Charles Lance Cowey, David C. Bibby, Gabriel Kremmidiotis, Elizabeth E. Doolin, Tina C. Lavranos, Guru Sonpavde, Noah M. Hahn, Christopher Sweeney, John Sarantopoulos. Phase I results of a phase I/II trial of BNC105P with everolimus in metastatic renal cell carcinoma (mRCC) patients previously treated with VEGFR tyrosine kinase inhibitors. J Clin Oncol 30, 2012 (suppl; abstr 4603) http://www.asco.org/ASCOv2/Meetings/Abstracts&vmview=abst_detail_view&confID=114&abstractID=91911

  • John Sarantopoulos, Long H. Dang, Richard C. Lauer, Alexander Starodub, Ralph J. Hauke, Matt D. Galsky, Kathryn A. Bylow, Charles Lance Cowey, David C. Bibby, Gabriel Kremmidiotis, Elizabeth E. Doolin, Tina C. Lavranos, Jose Luis Iglesias, Guru Sonpavde, Theodore Logan, Noah M. Hahn, Christopher Sweeney, Thomas E. Hutson. A phase I/II trial of BNC105P with everolimus in metastatic renal cell carcinoma (mRCC) patients: Updated phase I results of the Disruptor-1 trial. J Clin Oncol 31, 2013 (suppl; abstr 4563. http://abstracts2.asco.org/AbstView_132_107981.html

  • Pal S, Azad A, Bhatia S, Drabkin H, Costello B, Sarantopoulos J, Kanesvaran R, Lauer R, Starodub A, Hauke R, Sweeney CJ, Hahn NM, Sonpavde G, Richey S, Breen T, Kremmidiotis G, Leske A, Doolin E, Bibby DC, Simpson J, Iglesias J, Hutson T. A Phase I/II Trial of BNC105P with Everolimus in Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2015 Aug 1;21(15):3420-7. doi: 10.1158/1078-0432.CCR-14-3370. Epub 2015 Mar 18.

    PubMed 25788492

  • Yang ES, Nassar AH, Adib E, Jegede OA, Alaiwi SA, Manna DLD, Braun DA, Zarei M, Du H, Pal SK, Naik G, Sonpavde GP. Gene Expression Signature Correlates with Outcomes in Metastatic Renal Cell Carcinoma Patients Treated with Everolimus Alone or with a Vascular Disrupting Agent. Mol Cancer Ther. 2021 Aug;20(8):1454-1461. doi: 10.1158/1535-7163.MCT-20-1091. Epub 2021 Jun 9.

    PubMed 34108261

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Everolimus and BNC105P in people with Renal Cell Carcinoma, run by Hoosier Cancer Research Network at 108 sites in 3 countries.

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 8 inclusion and 14 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: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Australia, Singapore. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 24 May 2017). 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?

Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus. (time frame: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months). The study lists 3 primary outcomes in all. 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 NCT01034631, which also lists 4 linked publications.

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 11 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in