EUCTR2011-000195-34-BG进行中（未招募）1 期
A single arm, open-label, phase II, multicentre study to assess the safety of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma (BCC). - STEVIE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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
- •- Adult patients, >/=18 years of age
- •- Metastatic or locally advanced basal cell carcinoma considered inoperable or that surgery is contraindicated and radiotherapy is contraindicated or inappropriate
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 720
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 480
排除标准
- •- Concurrent anti-tumor therapy
- •- Completion of the most recent anti-tumor therapy less than 21 days prior to the initiation of treatment
- •- Uncontrolled medical illness
- •- Patients with one of the following rare hereditary conditions: galactose intolerance, primary hypolactasia, or glucose-galactose malabsorption
研究者
相似试验
进行中（未招募）
1 期
A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell CarcinomaEUCTR2011-000195-34-GBF. Hoffmann-La Roche Ltd.501
进行中（未招募）
1 期
A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell CarcinomaEUCTR2011-000195-34-NOF. Hoffmann-La Roche Ltd.501
进行中（未招募）
1 期
A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell CarcinomaEUCTR2011-000195-34-IEF. Hoffmann-La Roche Ltd.1,200
进行中（未招募）
1 期
A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinomaocally advanced or metastatic basal cell carcinoma (BCC)MedDRA version: 19.0Level: PTClassification code 10004146Term: Basal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-000195-34-CZF. Hoffmann-La Roche Ltd.501
进行中（未招募）
1 期
A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinomaocally advanced or metastatic basal cell carcinoma (BCC)MedDRA version: 14.1Level: PTClassification code 10004146Term: Basal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-000195-34-SEF. Hoffmann-La Roche Ltd.800