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Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma

This study has been completed.
Information provided by (Responsible Party):
Ho Yeong Lim, Samsung Medical Center Identifier:
First received: January 7, 2010
Last updated: May 13, 2014
Last verified: May 2014
The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma

Condition Intervention Phase
Advanced Biliary Tract Adenocarcinoma
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma: Multicenter, Multinational Study

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Time to progression [ Time Frame: 12months ]

Secondary Outcome Measures:
  • Safety profile [ Time Frame: 12 months ]
  • Response rate [ Time Frame: 12 months ]
  • Duration of response [ Time Frame: 12 months ]
  • Overall survival [ Time Frame: 12 months ]
  • Correlative analyses: EGFR mutational analysis, EGFR immunohistochemical staining, RAS mutational analysis, KIT, PDGFRA, PDGFRB, Beta-Catenin (CTNNB1) mutations [ Time Frame: 12 months ]

Enrollment: 59
Study Start Date: March 2009
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Sunitinib
Sunitinib, 37.5 mg orally once daily continuously, comprising a 4-week cycle
Drug: Sunitinib
Sunitinib 37.5 mg orally once daily continuously, comprising a 4-week cycle

Detailed Description:
Phase II study of sunitinib as second-line treatment in advanced biliary tract carcinoma: multicenter, multinational study

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01082809

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Ho yeong Lim, M.D,Ph.D Samsung Medical Center, Seoul, Korea
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ho Yeong Lim, Samsung Medical center, Samsung Medical Center Identifier: NCT01082809     History of Changes
Other Study ID Numbers: 2009-02-025
Study First Received: January 7, 2010
Last Updated: May 13, 2014

Keywords provided by Samsung Medical Center:
advanced biliary tract carcinoma

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors processed this record on May 25, 2017