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Completed

NCT Number: NCT01082809

Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma

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

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Key information

Conditions

Advanced Biliary Tract Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 18
  • 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

Treatment and study plan

Sunitinib

Drug

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

Primary outcomes

  1. Time to progression

    Time frame: 12months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 9, 2010
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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