An Extension Treatment Protocol for Subjects who have Participated in AV-951-09-301 study

Phase 3

• Registration Number: CTRI/2010/091/000025
• Lead Sponsor: AVEO Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 500

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified