Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT01253668
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01253668
Study Brief:
Protocol Section:
NCT01253668