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Clinical Trials/NCT01082809
NCT01082809
Completed
Phase 2

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

Samsung Medical Center1 site in 1 country59 target enrollmentMarch 2009
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ConditionsAdvanced Biliary Tract Adenocarcinoma
InterventionsSunitinib

Overview

Phase
Phase 2
Intervention
Sunitinib
Conditions
Advanced Biliary Tract Adenocarcinoma
Sponsor
Samsung Medical Center
Enrollment
59
Locations
1
Primary Endpoint
Time to progression
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
February 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ho Yeong Lim

Samsung Medical center

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

  • •histologically or cytologically confirmed adenocarcinoma of biliary tract
  • •unresectable or metastatic
  • •ECOG performance status of 0\~2
  • •measurable or evaluable lesion per RECIST criteria
  • •adequate marrow, hepatic, renal and cardiac functions
  • •One prior treatment of cytotoxic chemotherapy (including adjuvant treatment within 12 months)
  • •provision of a signed written informed consent

Exclusion Criteria

  • •severe co-morbid illness and/or active infections
  • •pregnant or lactating women
  • •active CNS metastases not controllable with radiotherapy or corticosteroids
  • •known history of hypersensitivity to study drugs

Arms & Interventions

Sunitinib

Sunitinib, 37.5 mg orally once daily continuously, comprising a 4-week cycle

Intervention: Sunitinib

Outcomes

Primary Outcomes

Time to progression

Time Frame: 12months

Secondary Outcomes

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

Study Sites (1)

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