A clinical trial study of Sunitinib in biliary tract carcinoma after failure of first line treatment
Phase 2
Completed
- Conditions
- Health Condition 1: null- biliary tract adenocarcinoma
- Registration Number
- CTRI/2010/091/000433
- Lead Sponsor
- Samsung Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 59
Inclusion Criteria
1 Age more tha 18 years
2 Histologically or cytologically confirmed adenocarcinoma of biliary tract
3 Unresectable or metastatic
4 ECOG performance status of 0 and 2
5 Measurable or evaluable lesion per RECIST criteria
6 Adequate marrow hepatic renal and cardiac functions
7 One prior treatment of cytotoxic chemotherapy including adjuvant treatment within 12 months
8 Provision of a signed written informed consent
Exclusion Criteria
1. Severe co-morbid illness and/or active infections
2. Pregnant or lactating women
3. Active CNS metastases not controllable with radiotherapy of corticosteroids
4. Known history of hypersensitivity to study drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method