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Phase II Study of Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma: Multicenter, Multinational Study


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Biliary Tract Adenocarcinoma

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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

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