Conditions: Carcinoma, Renal Cell
Keywords: Renal Cell Carcinoma AV-951 tivozanib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 272
Healthy volunteers: no

Brief summary:
This phase 2 trial is evaluating the antineoplastic activity of tivozanib (AV-951) in treating patients with recurrent or metastatic renal cell cancer. Tivozanib (AV-951) is a VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking blood flow to the tumor.

Detailed description:
Approximately 200 patients will be enroled into the initial, 16 week, open-label period using 1.5 mg/day dosing. Patients will receive tivozanib (AV-951) continuously for 3 weeks followed by 1 week off study drug. Patients will undergo disease assessment at baseline and after Cycles 2 and 4 and response will be determined by RESIST criteria.

After the initial, 16 week open-label period, disease status will be assessed and compared to baseline using modified RECIST criteria:

* Patients with greater than or equal to 25% tumor shrinkage will continue on their current dose of tivozanib (AV-951)
* Patients with less than 25% tumor change (growth or shrinkage) will be randomly assigned to double-blind tivozanib (AV-951) or matching placebo for 12 weeks
* Patients with greater than or equal to 25% tumor growth will be discontinued

Arms:
arm 1: Tivozanib (AV-951) administered as a solid dosage form daily for three weeks per month arm 2: solid oral capsule containing excipients dosed daily for three weeks per month

Interventions: intervention 1: Tivozanib (AV-951) intervention 2: Placebo comparator
Intervention descriptions: intervention 1: solid oral dosage form taken daily for three weeks per one month cycle intervention 2: solid oral capsule containing excipients dosed daily for three weeks per month

Protocol document: