Study to continue giving Tivozanib to subject participating in other studies with Tivozanib

Phase 1

• Conditions: Renal Cell Carcinoma Stage III, Renal Cell Carcinoma Stage IV, Metastatic Renal Cell Carcinoma,; MedDRA version: 16.1Level: LLTClassification code 10038400Term: Renal carcinoma stage IVSystem Organ Class: 100000004864; MedDRA version: 16.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864; MedDRA version: 16.1Level: LLTClassification code 10038399Term: Renal carcinoma stage IIISystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-28
• Last Update Posted: 22 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. The subject must have received tivozanib while enrolled in another protocol, must be tolerating study drug and must currently display clinical benefit.
a. Subjects who received tivozanib hydrochloride at any time while on
parent protocol AV-951-12-205, regardless of sequence, may enroll if
they tolerated and displayed clinical benefit while receiving tivozanib
hydrochloride.
b. Subjects receiving sorafenib in Study AV-951-09-902 who were
tolerating sorafenib and displaying clinical benefit at the time of study
termination may initiate tivozanib hydrochloride as a treatment option.
2.If female of childbearing potential, documentation of negative pregnancy test prior to enrollment.
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 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

1. > 4 weeks since discontinuation of study drug on a previous AVEO
sponsored clinical trial
For subjects initiating tivozanib hydrochloride (ie receiving sorafenib
and demonstrating tolerability and clinical benefit on Study AV-951-09-
902 at the time of study termination), > 4 weeks since last dose of
sorafenib, unless discussed with Sponsor.
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. All
fertile male and female subjects (and their partners) must agree to use a
highly effective method of contraception.
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 except
a) Subjects who received sunitinb, regardless of sequence, in Study AV-
951-12-205
b) Subjects who received sorafenib in Study AV-951-09-902 who were
tolerating study drug and displaying clinical benefit at the time of study
termination
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
4. Steroid therapy equivalent of prednisone > 10 mg/day
(except for steroid premedications used for paclitaxel administration).

Study & Design

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