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

• Register: EUCTR
• Last refreshed on: 19 October 2015
• Main ID: EUCTR2009-015987-32-IT
• Date of registration: 14/12/2009
• Prospective Registration: Yes
• Primary sponsor: AVEO PHARMACEUTICALS, INC.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 22/03/2010
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015987-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Bulgaria, France, Hungary, Italy, Poland, United Kingdom

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Advanced Renal Cell Carcinoma
MedDRA version: 9.1 Level: LLT Classification code 10050076

Intervention(s)

Product Name: Tivozanib
Product Code: AV-951
Pharmaceutical Form: Capsule, hard
CAS Number: 682745-41-1
Current Sponsor code: AV-951
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Product Name: Tivozanib
Product Code: AV-951
Pharmaceutical Form: Capsule, hard
CAS Number: 682745-41-1
Current Sponsor code: AV-951
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-

Trade Name: NEXAVAR*112CPR RIV 200MG
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Primary end point(s): Study drug may be continued in the absence of disease progression or intolerable toxicities

Main Objective: To allow access to tivozanib for subjects who participated in Protocol AV-951-09-301, and failed sorafenib treatment on protocol. To allow long-term access to tivozanib for subjects who participated in Protocol AV-951-09-301 and demonstrated clinical benefit and acceptable tolerability to tivozanib To allow long-term access to sorafenib for subjects who participated in Protocol AV-951-09-301 and demonstrated clinical benefit and acceptable tolerability to sorafenib To assess long-term safety in subjects who continue treatment with tivozanib

Secondary Objective: To determine the objective response rate (ORR), duration of response (DR), and progression-free survival (PFS) of subjects who continue treatment with tivozanib or sorafenib To determine the ORR, DR, and PFS of subjects who receive tivozanib after failure of sorafenib To determine overall survival (OS) of subjects who continue treatment with tivozanib or sorafenib

Secondary ID(s)

AV-951-09-902

2009-015987-32-FR