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A Phase 2, Placebo-Controlled, Randomized, Discontinuation Trial of Tivozanib (AV-951) in Patients With Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Carcinoma, Renal Cell

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Trial Information

A Phase 2, Placebo-Controlled, Randomized, Discontinuation Trial of Tivozanib (AV-951) in Patients With Renal Cell Carcinoma

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

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

- 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

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

- Myocardial infarction within 3 months prior to administration of first study

- 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

- Inability to comply with protocol requirements

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

To determine the safety of tivozanib (AV-951) with this dose schedule

Outcome Time Frame:

28 weeks after study entry

Safety Issue:


Principal Investigator

Dmitriy G Nosov, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences


United States: Food and Drug Administration

Study ID:




Start Date:

October 2007

Completion Date:

August 2010

Related Keywords:

  • Carcinoma, Renal Cell
  • Renal Cell Carcinoma
  • AV-951
  • tivozanib
  • Carcinoma
  • Carcinoma, Renal Cell