DRKS00003890已完成不适用
sage of Vinflunine i.v. (JAVLOR®) for the Treatment of Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium in Adult Patients After Failure of a Cisplatinum-containing Therapy - JONAS-1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •At least 18 years old
- •- Legally competent male and female patients
- •- Advanced or metastatic transitional cell carcinoma of the urothelium
- •- Failure of a prior Cisplatinum-containing treatment
- •- Performance Status 0 or 1
- •- Signed patient informed consent
排除标准
- •- Missing signed patient informed consent
- •- Performance Status 2 or higher
- •- Life expectancy < 2 months
- •- Brain metastases
- •- Creatinine-clearance < 20 ml/min
- •- Child-Pugh-stadium C
- •- Prothrombin time < 50%
- •- Bilirubin > 5 x ULN
- •- Transaminases > 6 x ULN
- •- Gamma-Glutamyl-transferase > 15 x ULN
- •- Pregnant or breast-feeding women
- •- Known/suspected hypersensitivity against vinflunine or other vinca-alkaloids
- •- Recent (within the last 2 weeks) or current severe infections
- •- Baseline ANC < 1,500/mm3 or platelets < 100,000/mm3
- •- Patients being institutionalised due to court/regulatory order
研究者
相似试验
已完成
不适用
JAVLOR® Online Non-Interventional TrialTransitional Cell CarcinomaNCT01103544Pierre Fabre Pharma GmbH200
进行中（未招募）
不适用
A Phase II Study of Intravenous (IV) Vinflunine in Patients with Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the UrotheliumRevised Protocol #05, incorporating Protocol Amendments 04, 07, 08 and 10;+ Pharmacokinetics Blood Sample Amendment #03 dated 18-Oct-05+ Amendment #06, dated 24-Feb-06Advanced Cancer, IV, NosEUCTR2005-001463-64-SEBristol-Myers Squibb International Corporation150
进行中（未招募）
不适用
A Phase II Study of Intravenous (IV) Vinflunine in Patients with Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the UrotheliumRevised Protocol #01, version 2.0 incorporating Protocol Amendment #04, andPharmacogenetics Blood Sample Amendment #01, dated 18-Oct-04Primary Tumor Tissue Sample Amendment #02, dated 18-Oct-04Pharmacokinetics Blood Sample Amendment #03, dated 18-Oct-04Advanced Cancer, IV, NosEUCTR2005-001463-64-ATBristol-Myers Squibb International Corporation150
进行中（未招募）
不适用
A phase II study of intravenous IV vinflunine in patients with locally advanced or metastatic transitional cell carcinoma TCC of the urothelium.EUCTR2005-001463-64-ITBRISTOL-M.SQUIBB160
进行中（未招募）
1 期
study of IV vinflunine in combination with methotrexate versus methotrexate alone in patients with recurrent or metastatic head and neck cancer previously treated with platinum-based chemotherapyrecurrent or metastatic squamous cell carcinoma of the head and neck previously treated with platinum-based chemotherapyMedDRA version: 18.1 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-005081-38-DEPIERRE FABRE MEDICAMENT459