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Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma

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.
 
ClinicalTrials.gov Identifier: NCT01082809
Recruitment Status : Completed
First Posted : March 9, 2010
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
Ho Yeong Lim, Samsung Medical Center

Brief Summary:
The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma

Condition or disease Intervention/treatment Phase
Advanced Biliary Tract Adenocarcinoma Drug: Sunitinib Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Ho yeong Lim, M.D,Ph.D Samsung Medical Center, Seoul, Korea
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ho Yeong Lim, Samsung Medical center, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01082809    
Other Study ID Numbers: 2009-02-025
First Posted: March 9, 2010    Key Record Dates
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:
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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
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action