EUCTR2009-013407-66-BE进行中（未招募）1 期
A Rollover Protocol to allow continued access to Tivozanib (AV-951) for subjects enrolled in other Tivozanib Protocols
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. The subject must have received tivozanib while enrolled in another protocol, must be tolerating study drug and must currently display clinical benefit.
- •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 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 96
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •1. > 4 weeks since discontinuation of study drug on a previous AVEO
- •sponsored clinical trial
- •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. 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.
- •4. Uncontrolled hypertension.
- •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
- •Drugs and treatments to be excluded and dietary restrictions during
- •study participation
- •The following medications are prohibited:
- •1. Systemic agents targeting the VEGF pathway except
- •a) Subjects who received sunitinb, regardless of sequence, in Study AV-
- •951-12-205
- •b) Subjects who received sorafenib in Study AV-951-09-902 who were
- •tolerating study drug and displaying clinical benefit at the time of study
- •termination
- •2. Chemotherapy, other signal transduction inhibitors, monoclonal
- •antibodies, immunotherapy or biological response modifiers (if taken as
- •part of parent protocol then allowed).
- •3. Cytochrome P450 (CYP3A4) inducers for the duration of study
- •4. Steroid therapy equivalent of prednisone > 10 mg/day
- •(except for steroid premedications used for paclitaxel administration).
研究者
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