Phase Ib study of tivozanib (AV-951) in combination with temsirolimus in patients with renal cell carcinoma.

ABSTRACT:

Background

Tivozanib is a potent and selective tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, -2 and -3, with a long half-life. Tivozanib has demonstrated clinical activity and acceptable tolerability in renal cell carcinoma (RCC). This phase Ib study determined the recommended phase II dose (RP2D) and evaluated the safety and clinical activity of tivozanib plus temsirolimus, a mammalian target of rapamycin inhibitor.

Patients and methods

Patients with advanced RCC were administered open-label tivozanib 0.5, 1.0 or 1.5mg/d orally (3 weeks on/1 week off) and temsirolimus 15 or 25 mg/week intravenously in a 3+3 dose-escalation design and subsequent expansion cohort.

Results

Of 27 patients treated, 20 patients had received ≥ 1 prior

SUBMITTER: Fishman MN 

PROVIDER: S-EPMC4666006 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature