A Phase 1b, Open-Label, Dose-Finding Study to Evaluate the Safety of Tivozanib (AV-951) in Combination With Temsirolimus in Subjects With Metastatic Renal Cell Carcinoma

Completed · Phase 1

Conditions studied: Renal Cell Carcinoma

In brief

The purpose of this study is to test the safety and tolerability of tivozanib (AV-951) and Torisel™ given in combination for renal cell cancer. The study will also assess the effects of the combination of tivozanib (AV-951) and Torisel™ on the tumor. 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. Temsirolimus is an mTOR inhibitor which is approved for the treatment of advanced renal cell carcinoma.

Key facts

Study ID

NCT00563147

Run by

AVEO Pharmaceuticals, Inc.

People needed

28

Starts

2007-11-01

Expected to finish

2011-02-01

Last updated by the study team

2011-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18-year-old males or females
• Histologically confirmed renal cell carcinoma with a clear cell component
• Documented progressive disease
• Measurable disease by RECIST criteria
• No more than 1 prior VEGF receptor targeted therapy; no prior treatment with temsirolimus or other drugs targeting the mTOR pathway
• Karnofsky performance status > 70%; life expectancy ≥ 3 months
• Ability to give written informed consent

You may not qualify if…

• Known hypersensitivity to temsirolimus or its metabolites (including sirolimus), polysorbate 80, or to any other component of the temsirolimus formulation
• Primary CNS malignancies; active CNS metastases
• Hematologic malignancies (including leukemia in 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:
• Fasting serum cholesterol > 350 mg/dL
• Fasting triglycerides > 400 mg/dL
• Total bilirubin > 1.5 × ULN
• AST or ALT > 2.5 × ULN (or > 5 x ULN in subjects with liver metastasis)
• Serum albumin < 3.0 g/dL
• Creatine > 1.5 × ULN (or calculated CLCR <50 mL/min/1.73 m2)
• Proteinuria > 2.5 g/24 hours or 3+ with urine dipstick
• Significant cardiovascular disease, including:
• Active clinically symptomatic left ventricular failure
• Active hypertension (diastolic blood pressure > 100 mmHg). Subjects 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 2 or more antihypertensive medications
• Myocardial infarction within 3 months prior to administration of first dose of study drug
• Subjects with delayed healing of wounds, ulcers, and/or bone fractures
• Pulmonary hypertension or pneumonitis
• Serious/active infection; infection requiring parenteral antibiotics
• Inadequate recovery from any prior surgical procedure; major surgical procedure within 6 weeks prior to study entry
• Uncontrolled psychiatric disorder, altered mental status precluding informed consent or necessary testing

Where it is running

• UCLA Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• The Methodist Hospital Research Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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