Study to continue giving Tivozanib hydrochloride to subjects participating in other studies with Tivozanib hydrochloride

• Conditions: Renal Cell Carcinoma Stage III, Renal Cell Carcinoma Stage IV, Metastatic Renal Cell Carcinoma,; MedDRA version: 14.1Level: LLTClassification code 10038400Term: Renal carcinoma stage IVSystem Organ Class: 100000004864; MedDRA version: 14.1Level: LLTClassification code 10038399Term: Renal carcinoma stage IIISystem Organ Class: 100000004864; MedDRA version: 14.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-013407-66-GB
• Lead Sponsor: AVEO Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-30
• Last Update Posted: 23 December 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. The subject must have received tivozanib hydrochloride while enrolled in another protocol, must be tolerating study drug and must currently display clinical benefit.
2.If female of childbearing potential, documentation of negative pregnancy test prior to enrollment (i.e. before the first dose of tivozanib hydrochloride in this protocol).
3.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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.> 4 weeks since discontinuation of study drug on a previous AVEO sponsored clinical trial
2.Pregnant or lactating
3.Sexually active male and pre-menopausal female subjects (and their partners) unless they agree to use adequate contraceptive measures, while on study and for 45 days after the last dose of study drug.
4.Uncontrolled hypertension
5.Unhealed wounds (including active peptic ulcers)
6.Serious/active infection or infection requiring parenteral antibiotics
7.Life-threatening illness or organ system dysfunction compromising safety evaluation
8.Psychiatric disorder, altered mental status precluding informed consent or necessary testing
9.Inability to comply with protocol requirements

Drugs and treatments to be excluded and dietary restrictions during study participation

The following medications are prohibited:
1.Systemic agents targeting the VEGF pathway
2.Chemotherapy, other signal transduction inhibitors, monoclonal antibodies, immunotherapy or biological response modifiers (if taken as part of parent protocol then allowed).
3.Cytochrome P450 (CYP3A4) inducers for the duration of study treatment

Study & Design

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