None listed
Conditions
Interventions
Intervention1: Tivozanib: 1.5 mg Orally once daily or dose at which AV-951-09-301 study is completed &
continued in the absence of disease progression or intolerable toxicities or until Tivozanib becomes commercially available in the country.
Control Intervention1: Sorafenib: Dose at which AV-951-09-30
continued in the absence of disease progression or intolerable toxicities or until Tivozanib becomes commercially available in the country.
Sponsors
AVEO Pharmaceuticals, Inc
Eligibility
Inclusion 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 less and equal to 2 (see Appendix C) and life expectancy greater and equal to 3 months. 3. If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment. 4. Ability to give written informed consent
Exclusion criteria
Exclusion criteria: Subjects to be excluded 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. All fertile male and female subjects (and their partners) must agree to use a highly effective method of contraception. Effective birth control includes (a) IUD plus one barrier method; or (b) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). (Note: Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are not considered effective for this study.) 6. Uncontrolled hypertension: systolic blood pressure > 150 mmHg or diastolic blood pressure >100 mmHg on 2 or more antihypertensive medications, documented on 2 consecutive measurements taken at least 24 hours apart. 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, altered mental status precluding informed consent or necessary testing 11. Inability to comply with protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) To allow access to tivozanib for subjects who participated in Protocol AV-951-09-301, and failed sorafenib treatment on protocol. (b) 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 (c) 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 (d) To assess longterm safety in subjects who continue treatment with tivozanibTimepoint: Patient continuing on Sorafenib or Tivozanib treatment for Protocol AV-951-09-301 | — |
Secondary
| Measure | Time frame |
|---|---|
| (a) 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 (b) To determine the ORR, DR, and PFS of subjects who receive tivozanib after failure of sorafenib (c) To determine overall survival (OS) of subjects who continue treatment with tivozanib or sorafenibTimepoint: Radiology studies (CT scan or MRI) will be performed on the day of End of cycles 2 and every EVEN numbered cycle. | — |
Countries
India
Contacts
Public ContactDr. Pramod Kabra
Outcome results
None listed