EUCTR2009-013407-66-GB进行中（未招募）不适用
A Rollover Protocol to allow continued access to Tivozanib hydrochloride (AV-951) for subjects enrolled in other Tivozanib hydrochloride Protocols
试验速览
- 阶段
- 不适用
- 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 hydrochloride 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 (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
排除标准
- •1.> 4 weeks since discontinuation of study drug on a previous AVEO sponsored clinical trial
- •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.
- •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
- •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 treatment
研究者
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