Clinical trial · Interventional
Brivanib Metastatic Renal Cell Carcinoma
Brivanib (BMS-582664, Brivanib Alaninate) in Treatment of Refractory Metastatic Renal Cell Carcinoma - A Phase II Pharmacodynamic and Baseline Biomarker Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): In November 2012, this study was permanently closed to new accrual at the request of the drug manufacturer (BMS), who decided not to pursue additional research activity in this patient population.
Summary
Brief summary (as posted)
This is a phase II study of an investigational agent, brivanib, in patients with refractory metastatic renal cell carcinoma. This study will evaluate the safety and effectiveness of brivanib in renal cell carcinoma, and explore the activity of this drug in this population to determine whether imaging and molecular features of the tumors can be used to predict response. Approximately 30 people with advanced kidney cancer will be enrolled on this study at the University of Pennsylvania.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brivanib alaninate | Drug | — | UNRESOLVED |
| Immunohistochemistry | Other | — | UNRESOLVED |
| Iodine I 124 chimeric monoclonal antibody G250 | Other | — | UNRESOLVED |
| Polymerase chain reaction | Genetic | — | UNRESOLVED |
| Positron emission tomography/computed tomography | Procedure | — | UNRESOLVED |
| Protein expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Patients receive oral brivanib alaninate daily in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Brivanib alaninate
- Genetic: Polymerase chain reaction
- Other: Iodine I 124 chimeric monoclonal antibody G250
- Procedure: Positron emission tomography/computed tomography
- Genetic: Protein expression analysis
- Other: Immunohistochemistry
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 16 weeks
- description
- All patients will be followed through the entire 16-week period and will be given a binary outcome assignment: progressive disease or not.
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female adults with metastatic renal cell carcinoma * Patients will have tumors that bear a clear cell component that comprises greater than or equal to 50% of the tumor. * Disease must be measurable in accord with RECIST 1.1 guidelines. * Patients who have developed progressive disease or intolerance on treatment with sorafenib, sunitinib, bevacizumab, or pazopanib over a 60 day period who have not discontinued this therapy more than 100 days prior to study enrollment. Progressive disease per RECIST 1.1 guidelines will be preferred * Therapy with up to three prior systemic regimens will be allowed. * Patients may have been treated with any of the following: sorafenib, sunitinib, bevacizumab, pazopanib, temsirolimus, everolimus, interferon alpha, interleuken-2. * Treatment with up to one prior regimen that included cytotoxic chemotherapy will be allowed. * Patients may have been treated with more than 1 antiangiogenic therapy (e.g., patients may have been treated with both sorafenib and sunitinib or sunitinib and bevacizumab, or sequential combinations that include pazopanib). * Life expectancy of at least 3 months * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Tumor tissue must be available for correlative studies. * Patients must consent to allow the acquisition of formalin-fixed paraffin-embedded (FFPE) material (block or unstained slides) by study personnel for performance of correlative tissue studies. Exclusion Criteria: * Known brain metastases * Prior therapy with brivanib, or anti-FGFR (fibroblast growth factor receptor) therapy. * History of thrombotic or embolic events within the last six months such as a cerebrovascular accident (including transient ischemic attacks), pulmonary embolism. * Gastrointestinal bleeding or any other hemorrhage/bleeding event CTCAE version 4.0 Grade greater than 3 within 30 days prior to study entry. * Uncontrolled or significant cardiovascular disease. * QTc greater than 450 msec on two consecutive ECGs (Baseline ECG should be repeated if QTc is found to be greater than 450 msec.). * Active infection, less than 7 days after completing systemic antibiotic therapy. * History of non-healing wounds or ulcers or bone fractures within 3 months of fracture. * Major surgical procedure, open biopsy, or significant traumatic injury less than 3 weeks prior to study enrollment or those who receive minor surgical procedures (e.g. core biopsy or fine needle aspiration)within 1 week prior to study enrollment. * Cytotoxic chemotherapy within 3 weeks, bevacizumab within 2 months, or radiation therapy within 2 weeks, other targeted therapies (e.g., sorafenib, sunitinib, temsirolimus, everolimus)within 2 days. * Inability to swallow tablets or untreated malabsorption syndrome. * Pre-existing thyroid abnormality with thyroid function that cannot be controlled with medication. * History of HIV * Patients with centrally cavitating lung lesions. * Patients requiring therapeutic anticoagulation with warfarin at baseline. However, prophylactic therapy with a low molecular weight heparin at baseline is acceptable.
References
Publications (0)
Data not yet available