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Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082809
First Posted: March 9, 2010
Last Update Posted: May 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ho Yeong Lim, Samsung Medical Center
  Purpose
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: None (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 Ho Yeong Lim, 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
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082809


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ho Yeong Lim, Samsung Medical center, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01082809     History of Changes
Other Study ID Numbers: 2009-02-025
First Submitted: January 7, 2010
First Posted: March 9, 2010
Last Update Posted: May 14, 2014
Last Verified: May 2014

Keywords provided by Ho Yeong Lim, Samsung Medical Center:
advanced biliary tract carcinoma
Sunitinib

Additional relevant MeSH terms:
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors