Study to continue giving Tivozanib Hydrochloride to subject 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: 100000004864MedDRA version: 14.1Level: LLTClassification code 10038399Term: Renal carcinoma stage IIISystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-013407-66-DE
- Lead Sponsor
- AVEO Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
1.The subject must have received tivozanib hydrochloride 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 (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 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64
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.
4. Uncontrolled hypertension
5. Newly identified CNS malignancies or documented progression of CNS metastases
6. Unhealed wounds (including active peptic ulcers)
7. Serious/active infection or infection requiring parenteral antibiotics
8. Life-threatening illness or organ system dysfunction compromising safety evaluation
9. Psychiatric disorder, altered mental status precluding informed consent or necessary testing
10. 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
- Primary Outcome Measures
Name Time Method Main Objective: To allow continued access to tivozanib hydrochloride for subjects who have participated in other tivozanib hydrochloride(monotherapy, combination or crossover) protocols, who are tolerating study drug and displaying clinical benefit.<br>;Secondary Objective: To assess long-term adverse events and serious adverse events in<br>subjects who continue on tivozanib hydrochloride<br>To provide to tivozanib hydrochloride as a treatment option for subjects<br>who received sorafenib in Study AV-951-09-902 and were tolerating<br>sorafenib and displaying clinical benefit at the time of study termination;Primary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not applicable
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: not applicable