A Study of Tivozanib (AV-951), an Oral VEGF Receptor Tyrosine Kinase Inhibitor, in the Treatment of Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AVEO Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• ≥ 18 year old males or females

• Patients with recurrent or metastatic renal cell carcinoma (RCC) or primary RCC that is not amendable to surgical intervention

• Histologically or cytologically confirmed renal cell carcinoma

• Measurable disease

• No more than one prior systemic treatment (chemotherapy or immunotherapy) for RCC.

• No active brain metastases

• Karnofsky performance status ≥ 70%, life expectancy ≥ 3 months

• No childbearing potential, or use of effective contraception during the study and for 4 weeks after the last dose of study drug

• Archival paraffin embedded tumor tissue, if available.

• Ability to give written informed consent

Exclusion Criteria:

• Pregnant or lactating women

• Primary CNS malignancies; active CNS metastases

• Hematologic malignancies (includes: leukemia, any form; lymphoma; and multiple myeloma)

• Any of the following hematologic abnormalities:

• Hemoglobin ≤ 9.0 g/dL

• ANC < 1500 per mm3

• Platelet count < 100,000 per mm3

• Any of the following serum chemistry abnormalities:

• Total bilirubin > 1.5 × the ULN

• AST or ALT ≥ 2.5 × the ULN

• Serum albumin < 3.0 g/dL

• Creatinine > 1.7 × ULN (or calculated CLCR <50 mL/min/1.73 m2)

• Proteinuria > 2.5 g/24 hours or 4+ with urine dipstick

• Significant cardiovascular disease, including:

• Active clinically symptomatic left ventricular failure

• Active HTN (diastolic blood pressure > 100 mmHg). Patients with a history of hypertension must have been on stable doses of anti-hypertensive drugs for ≥ 4 weeks

• Uncontrolled hypertension: Blood pressure >140/90 mmHg on more than 2 antihypertensive medications.

• Myocardial infarction within 3 months prior to administration of first study dose

• Unhealed wounds (including active gastric ulcers)

• Serious/active infection; infection requiring parenteral antibiotics

• Inadequate recovery from prior antineoplastic therapy

• Inadequate recovery from any prior surgical procedure; major surgical procedure within 4 weeks prior to study entry

• Life-threatening illness or organ system dysfunction compromising safety evaluation

• Psychiatric disorder, altered mental status precluding informed consent or necessary testing

• Inability to comply with protocol requirements