EUCTR2009-013407-66-FR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）
- 入组人数
- 225
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.
- •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
排除标准
- •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
研究者
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