CTRI/2010/091/000433
Completed
Phase 2
Phase II study of Sunitinib as second line-treatment in advanced biliary tract carcinoma: multicentre, multinational study
Samsung Medical Centre0 sites59 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Samsung Medical Centre
- Enrollment
- 59
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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