An Extension Treatment Protocol for Subjects who have Participated in a Phase 3 Study of Tivozanib Hydrochloride vs. Sorafenib in Renal Cell Carcinoma (Protocol AV-951-09-301)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 350

Inclusion Criteria

Subjects who have discontinued treatment in the AV-951-09-301 protocol and have been undergoing tumor assessment and/or survival follow-up will not need to meet the eligibility criteria (defined below) for their long term follow-up in the current study.
1. The subject must have participated on Protocol AV-951-09-301, and must meet either of the following bulleted criteria:
- Demonstrated disease progression 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 hydrochloride or sorafenib on protocol AV-951-09-301
2. ECOG performance status = 2 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

1. Newly identified CNS malignancies or documented progression of CNS metastases; subjects will be allowed only if the CNS metastases have been adequately treated with radiotherapy or surgery. For subjects receiving steroid therapy please refer to Section 6.3 for allowed steroid maintenance therapy
Duration since last dose on Protocol AV-951-09-301:
2. For subjects continuing tivozanib hydrochloride or sorafenib (subjects who demonstrated clinical benefit and acceptable tolerability during treatment with tivozanib hydrochloride or sorafenib on protocol AV-951-09-301): more than 2 weeks since last dose of tivozanib hydrochloride or sorafenib
For subjects initiating tivozanib hydrochloride (ie demonstrated disease progression during treatment with sorafenib): more than 4 weeks since last dose of sorafenib. Subjects demonstrating disease progression due to CNS metastasis will be allowed up to 8 weeks since last dose of sorafenib in order to complete treatment for CNS metastasis
3.Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug
4.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
5.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
6.If female, pregnant or lactating
7.Sexually active pre-menopausal female subjects (and female partners of male subjects) must use adequate contraceptive measures while on study and for at least 50 days after the last dose of study drug. Sexually active male subjects must use adequate contraceptive measures, while on study and for at least 90 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.)
8.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.
9.Unhealed wounds (including active peptic ulcers)
10.Serious/active infection or infection requiring parenteral antibiotics
11.Life-threatening illness or organ system dysfunction compromising safety evaluation
12.Psychiatric disorder, altered mental status precluding informed consent or necessary testing
13.Inability to comply with protocol requirements
14.Treatment with another anti-cancer therapy or participation in another interventional protocol (excluding AV-951-09-301)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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