Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma

May 13, 2014 updated by: Ho Yeong Lim, Samsung Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: 12months
12months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Ho yeong Lim, M.D,Ph.D, Samsung medical center, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

January 7, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-02-025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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