An Extension Treatment Protocol for Subjects who have Participated in a Phase 3 Study of Tivozanib vs. Sorafenib in Renal Cell Carcinoma (Protocol AV-951-09-301) - ND

• Conditions: Advanced Renal Cell Carcinoma; MedDRA version: 9.1Level: LLTClassification code 10050076

• Registration Number: EUCTR2009-015987-32-IT
• Lead Sponsor: AVEO PHARMACEUTICALS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-14
• Last Update Posted: 19 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. The subject must have participated on Protocol AV-951-09-301, and must meet at least one of the following criteria:  Demonstrated disease progression (DP) er RECIST during treatment with sorafenib, OR  Demonstrated clinical benefit [complete response (CR), partial response (PR), or stable disease (SD) per RECIST] and acceptable tolerability after treatment with tivozanib or sorafenib for up to 2 years on protocol AV-951-09-301 2. ECOG performance status ≤ 2 (see Appendix C) and life expectancy ≥ 3 months. 3. If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment. 4. Ability to give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. More than 4 weeks since discontinuation of tivozanib or sorafenib treatment on Protocol AV-951-09-301 2. Any of the following hematologic abnormalities: Hemoglobin < 9.0 g/dL ANC < 1500 per mm3 Platelet count < 75,000 per mm3 PT or PTT >1.5 ? ULN 3. Any of the following serum chemistry abnormalities: Total bilirubin > 1.5 ? ULN (or > 2.5 ? ULN for subjects with Gilbert s syndrome) AST or ALT > 2.5 ? ULN (or > 5 ? ULN for subjects with liver metastasis) Alkaline phosphatase > 2.5 ? ULN (or > 5 ? ULN for subjects with liver or bone metastasis) Creatinine > 2.0 ? ULN Proteinuria > 3+ by urinalysis or urine dipstick 4. If female, pregnant or lactating 5. Sexually active male and pre-menopausal female subjects (and their partners) unless they agree to use adequate contraceptive measures, while on study and for 30 days after the last dose of study drug. 6. Uncontrolled hypertension: systolic blood pressure > 150 mmHg or diastolic blood pressure >100 mmHg on 2 or more antihypertensive medications, 7. Unhealed wounds (including active peptic ulcers) 8. Serious/active infection or infection requiring parenteral antibiotics 9. Life-threatening illness or organ system dysfunction compromising safety evaluation 10. Psychiatric disorder, 11. Inability to comply with protocol requirements

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified