Study to continue giving Tivozanib to subject participating in other studies with Tivozanib

Phase 1

• Conditions: Renal Cell Carcinoma Stage III, Renal Cell Carcinoma Stage IV, Metastatic Renal Cell Carcinoma,; MedDRA version: 14.1Level: LLTClassification code 10038399Term: Renal carcinoma stage IIISystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 14.1Level: LLTClassification code 10038400Term: Renal carcinoma stage IVSystem Organ Class: 100000004864; MedDRA version: 14.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864

• Registration Number: EUCTR2009-013407-66-FR
• Lead Sponsor: AVEO Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-11
• Study Completion: 2015-06-23
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

1. The subject must have received tivozanib while enrolled in another protocol, must be tolerating study drug and must currently display clinical benefit.
2.If female of childbearing potential, documentation of negative pregnancy test prior to enrollment.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.> 4 weeks since discontinuation of treatment on a previous protocol
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 30 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.Agents targeting the VEGF pathway
2.Chemotherapy, other signal transduction inhibitors, monoclonal antibodies, immunotherapy or biological response modifiers (if taken as part of parent protocol then allowed).
3.Systemic hormonal therapy, during the study with the exception of:
•Hormonal therapy for appetite stimulation or contraception
•Nasal, ophthalmic, inhaled and topical steroid preparations
•Androgen suppression therapy for non-metastatic prostate carcinoma
•Hormone replacement therapy for conditions such as adrenal insufficiency, hypothyroidism, etc
•Low-dose maintenance steroid therapy (equivalent of prednisone = 10mg/day) for other conditions
4.Treatment with radiotherapy (limited radiotherapy involving < 25% of bone marrow may be allowed for palliative purposes after consultation with the medical monitor, treatment with study drug must be stopped during radiotherapy).
5.Herbal preparations/supplements (including daily multivitamin/mineral supplement containing herbal components).
6.Treatment with cytochrome P450 (CYP3A4) inducers or inhibitors (see Appendix A for examples).
7.Treatment with full-dose oral anticoagulants such as warfarin, acenocoumarol, fenprocoumon, or similar agents (full dose anticoagulation with low molecular weight heparin or unfractionated heparin administered subcutaneously, or low dose oral anticoagulation that does not increase INR >1.5 X ULN, are allowed).
8.Grapefruit and grapefruit juice

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To allow continued access to tivozanib for subjects who have participated in other tivozanib (monotherapy or combination) protocols, who are tolerating study drug and displaying clinical benefit.<br>;Secondary Objective: To assess long-term safety and tolerability in subjects who continue on tivozanib<br><br>To determine the duration of response and progression-free survival (PFS) of subjects who continue on tivozanib<br><br>;Primary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not applicable

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: not applicable