Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ho Yeong Lim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01082809
First received: January 7, 2010
Last updated: May 13, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Samsung Medical Center

Additional 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
Study First Received: January 7, 2010
Last Updated: May 13, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
advanced biliary tract carcinoma
Sunitinib

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

ClinicalTrials.gov processed this record on October 23, 2014