Renal Cell Carcinoma Stage III, Renal Cell Carcinoma Stage IV, Metastatic Renal Cell Carcinoma, MedDRA version: 14.1 Level: LLT Classification code 10038400 Term: Renal carcinoma stage IV System Organ Class: 100000004864 MedDRA version: 14.1 Level: LLT Classification code 10038399 Term: Renal carcinoma stage III System Organ Class: 100000004864 MedDRA version: 14.1 Level: LLT Classification code 10050076 Term: Metastatic renal carcinoma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Tivozanib Hydroclhoride
Product Code: 1.0 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tivozanib Hydrocholoride
CAS Number: 682745-41-1
Current Sponsor code: AV-951
Other d
Sponsors
AVEO Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria
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. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: To assess long-term adverse events and serious adverse events in subjects who continue on tivozanib hydrochloride To provide to tivozanib hydrochloride as a treatment option for subjects who received sorafenib in Study AV-951-09-902 and were tolerating 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium, Bulgaria, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
Public ContactTiffany Crowell
AVEO Pharmaceuticals, Inc.
Outcome results
None listed