DRKS00003397进行中（未招募）2 期
Prospectively randomized, double-blind, multicenter phase II trial comparing the efficacy of chemotherapy with gemcitabine plus cisplatin and sorafenib versus gemcitabine plus cisplatin and placebo in the treatment of advanced or metastatic urothelial carcinoma SUSE - AB 31/05 - SUSE - AB 31/05
niversitätsklinikum Essen0 个研究点目标入组 99 人开始时间: 2012年1月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 99 Years（—）
- 性别
- All
入选标准
- •Condition ECOG(Eastern Cooperative Oncology Group) 0-1
- •- Life expectancy at least 12 weeks
- •- Women in conceptional age: negative pregnancy test and adequate contraception (oral contraceptive, spiral); at men adequate contraception of the man (condom use) to 3 months after discontinuation of therapy with sorafenib
- •- Histologically or cytologically proven urothelial carcinoma of the bladder or upper urinary tract
- •- Locally advanced or metastatic urothelial carcinoma of the bladder or upper urinary tract (T3b,T4/ N+/M+)
- •- At least one unidimensional measurable lesion on CT(Computed Tomography) or MRI(Magnetic resonance imaging) according to RECIST(Response Evaluation Criteria in Solid Tumors) criteria
- •- Adequate hematologic, renal, hepatic and coagulation-physiological functions
排除标准
- •- Absence of the above inclusion criteria
- •- Dialysis after nephrectomy
- •- Patients with brain tumors and / or brain metastases
- •- Previous or existing serious cardiovascular (grade III - IV according to NYHA(New York Heart Association)) disease, active angina pectoris or ischemia, myocardial infarction within 6 months prior to enrollment, or patients with serious cardiac arrhythmias requiring antiarrhythmic therapy (beta blockers and digoxin are permitted)
- •- Patients with uncontrolled high blood pressure, systolic blood pressure> 150 mm Hg or diastolic pressure> 90 mmHg despite optimal medical treatment
- •- Patients with thrombotic or embolic events such as stroke or pulmonary embolism
- •- Patients with recently or known bleeding diathesis
- •- Known significant neurological or psychiatric diseases including dementia and epileptic seizures
- •- Serious inflammatory eye disease, hearing impairment
- •- Pulmonary (pO2(Blood oxygen) <60 mm Hg(Millimeters of mercury)), hematopoietic (eg(exempli gratia) severe bone marrow aplasia), hepatic or renal disease
- •- Patients with poorly controlled diabetes mellitus
- •- Serious bacterial or fungal infections(>Grade 2 NCI-CTC(National Cancer Institute-Common Terminology Criteria) Version 3)
- •- chronic hepatitis B or C, HIV(human immunodeficiency virus) infection
- •- Autoimmune disease
研究者
相似试验
进行中（未招募）
不适用
A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitisActive ulcerative colitisMedDRA version: 17.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2012-001830-32-LTDr. Falk Pharma GmbH400
进行中（未招募）
不适用
A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitisActive ulcerative colitisMedDRA version: 16.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2012-001830-32-PLDr. Falk Pharma GmbH400
进行中（未招募）
不适用
Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCTreatment of ulcerative colitisMedDRA version: 9.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisEUCTR2006-005377-22-CZDr. Falk Pharma GmbH360
进行中（未招募）
1 期
A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitisActive ulcerative colitisMedDRA version: 17.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2012-001830-32-HUDr. Falk Pharma GmbH400
进行中（未招募）
不适用
Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCTreatment of ulcerative colitisMedDRA version: 9.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisEUCTR2006-005377-22-LTDr. Falk Pharma GmbH360