Advanced Renal Cell Carcinoma MedDRA version: 12.0 Level: LLT Classification code 10050513 Term: Metastatic renal cell carcinoma
Conditions
Interventions
Product Name: Tivozanib (AV-951)
Product Code: 1.0 mg
Pharmaceutical Form: Capsule, hard
CAS Number: 682745-41-1
Current Sponsor code: Tivozanib (AV-951)
Other descriptive name: KRN951
Concentration u
Sponsors
AVEO Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
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) per 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 = 2 (see Appendix C) and life expectancy = 3 months. 3. If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment. 4. 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
Exclusion criteria: 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 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 |
|---|---|
| Main Objective: • To allow access to tivozanib for subjects who participated in Protocol AV-951-09-301, and failed sorafenib treatment on protocol. • 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 • 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 • To assess long-term safety in subjects who continue treatment with tivozanib;Secondary Objective: • 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 • To determine the ORR, DR, and PFS of subjects who receive tivozanib after failure of sorafenib • To determine overall survival (OS) of subjects who continue treatment with tivozanib or sorafenib;Primary end point(s): Study drug may be continued in the absence of disease progression or intolerable toxicities Discontinuation: Subjects experiencing unacceptable toxicities or with documented disease progression will be discontinued from further participation in this study. However, if a subject is continuing on sorafenib from Protocol AV-951-09-301 and demonstrates disease progression on sorafenib during this protocol, the subject may begin treatment with tivozanib and continue treatment until documented disease progression or unacceptable toxicity related to tivozanib. This study will be discontinued when tivozanib becomes commercially available in the country where the subject is being treated. If a subject is experiencing clinical benefit from tivozanib when the study is discontinued, the sponsor will assist the subject in obtaining commercially available tivozanib. | — |
Countries
Bulgaria, Czech Republic, France, Hungary, Italy, Poland, United Kingdom
Outcome results
None listed