EUCTR2009-013407-66-DE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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
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.
- •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 (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 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.
- •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. 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 treatment
- •4. Steroid therapy equivalent of prednisone > 10 mg/day
- •(except for steroid premedications used for paclitaxel administration).
研究者
相似试验
进行中（未招募）
不适用
Study to continue giving Tivozanib hydrochloride to subjects participating in other studies with Tivozanib hydrochlorideEUCTR2009-013407-66-GBAVEO Pharmaceuticals, Inc.
进行中（未招募）
1 期
Study to continue giving Tivozanib to subject participating in other studies with TivozanibRenal Cell Carcinoma Stage III, Renal Cell Carcinoma Stage IV, Metastatic Renal Cell Carcinoma,MedDRA version: 16.1Level: LLTClassification code 10038400Term: Renal carcinoma stage IVSystem Organ Class: 100000004864MedDRA version: 16.1Level: LLTClassification code 10038399Term: Renal carcinoma stage IIISystem Organ Class: 100000004864MedDRA version: 16.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864EUCTR2009-013407-66-BEAVEO Pharmaceuticals, Inc.
进行中（未招募）
不适用
Een rollover-protocol om voortgezette toegang tot tivozanib hydrochloride(AV-951) mogelijk te maken voor proefpersonen die in andere protocols met tivozanib hydrochloride ingeschreven wareEUCTR2009-013407-66-NLAVEO Pharmaceuticals, Inc.
已完成
2 期
A Rollover Protocol to allow continued access to Tivozanib Hydrochloride (AV-951) for subjects enrolled in other Tivozanib Hydrochloride Protocolsgastrointestinal cancer10027656NL-OMON39584AVEO pharamaceuticals10
进行中（未招募）
1 期
Study to continue giving Tivozanib to subject participating in other studies with TivozanibRenal Cell Carcinoma Stage III, Renal Cell Carcinoma Stage IV, Metastatic Renal Cell Carcinoma,MedDRA version: 14.1Level: LLTClassification code 10038400Term: Renal carcinoma stage IVSystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10038399Term: Renal carcinoma stage IIISystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864EUCTR2009-013407-66-FRAVEO Pharmaceuticals, Inc.225