Trial Information
Phase II Study of Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma: Multicenter, Multinational Study
Phase II study of sunitinib as second-line treatment in advanced biliary tract carcinoma:
multicenter, multinational study
Inclusion Criteria:
1. age ≥ 18
2. histologically or cytologically confirmed adenocarcinoma of biliary tract
3. unresectable or metastatic
4. ECOG performance status of 0~2
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 or corticosteroids
4. known history of hypersensitivity to study drugs
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression
Safety Issue:
Yes
Principal Investigator
Ho yeong Lim, M.D,Ph.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
Samsung Medical Center, Seoul, Korea
Authority:
Korea: Food and Drug Administration
Study ID:
2009-02-025
NCT ID:
NCT01082809
Start Date:
March 2009
Completion Date:
February 2012
Related Keywords:
- Advanced Biliary Tract Adenocarcinoma
- advanced biliary tract carcinoma
- Sunitinib
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Carcinoma