Een rollover-protocol om voortgezette toegang tot tivozanib hydrochloride(AV-951) mogelijk te maken voor proefpersonen die in andere protocols met tivozanib hydrochloride ingeschreven ware

• Conditions: Gastrointestinal cancer; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-30
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. The subject must have received tivozanib hydrochloride while enrolled in another protocol, must be tolerating study drug and must currently display clinical benefit. The length of time that a subject must be on the parent protocol before rolling over to this protocol will be dictated by the parent protocol.
a. Subjects who received tivozanib hydrochloride at any time while on parent protocol AV-951-12-205, regardless of sequence, may enroll if they tolerated and displayed clinical benefit while receiving tivozanib hydrochloride.
b. Subjects receiving sorafenib in Study AV-951-09-902 who were tolerating sorafenib and displaying clinical benefit at the time of study termination may initiate tivozanib hydrochloride as a treatment option.
2. If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment (i.e. before the first dose of tivozanib hydrochloride in this protocol).
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. Subjects to be excluded > 4 weeks since discontinuation of study drug treatment on a previous AVEO-sponsored clinical trial.
a. For subjects initiating tivozanib hydrochloride (ie receiving sorafenib and demonstrating tolerability and clinical benefit on Study AV-951-09-902 at the time of study termination), > 4 weeks since last dose of sorafenib, unless discussed with Sponsor. •
2. If female, 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 45 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. Highly effective birth control includes (a) IUD plus one barrier method; (b) oral, implantable or injectable contraceptive plus one barrier method; or (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm).
4. Uncontrolled hypertension: systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg documented on 2 consecutive measurements taken at least 24 hours apart.
5. Unhealed wounds (including active peptic ulcers).
6. Serious/active infection or infection requiring parenteral antibiotics.
7. Life-threatening illness or organ system dysfunction compromising safety evaluation.
8. Psychiatric disorder, altered mental status precluding informed consent or necessary testing.
9. Inability to comply with protocol requirements.

Study & Design

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