Brivanib Metastatic Renal Cell Carcinoma

This is an interventional treatment trial for Renal Cell Carcinoma Read More

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.