A Study of Vinflunine in Patients With Gastric Cancer

February 27, 2010 updated by: Bristol-Myers Squibb

A Multicenter, Single-Arm, Phase II Study of Single-Agent Vinflunine in the Second-line Treatment of Patients With Gastric Cancer

The purpose of this study is to learn if vinflunine can shrink or slow the growth of cancer in patients with advanced or metastatic stomach cancer who have progressed on a prior treatment with a fluoropyrimidine or taxane-containing chemotherapy regimen. The safety of this treatment will also be studied.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Phase 2
  • Phase 3

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

  • Korea, Republic of
      • Gyeonggi-Do, Korea, Republic of, 410-769
        • Local Institution
      • Seoul, Korea, Republic of, 120-752
        • Local Institution
      • Seoul, Korea, Republic of, 136-705
        • Local Institution
    • Gyeonggi-Do
      • Suwon-Si, Gyeonggi-Do, Korea, Republic of, 442-723
        • Local Institution
  • Malaysia
    • Negeri Sembilan
      • Nilai, Negeri Sembilan, Malaysia, 71800
        • Local Institution
  • Philippines
      • Quezon City, Philippines, 1102
        • Local Institution

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:

  • Patients with locally advanced or metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction who have progressed on a fluoropyrimidine or taxane-containing regimen in any combination in one prior first line treatment.
  • EGOC performance status of 0,1 or 2
  • Men and women, 18 years of age and older

Exclusion Criteria:

  • Patients having received more than one previous systemic chemotherapy regimen in any setting.
  • Major abdominal surgery within 2 months or any other surgery under general anesthesia within 4 weeks
  • Unresolved occlusive or sub-occlusive intestinal disease or any significant chronic intestinal disease (e.g. ulcerative colitis)
  • Prior radiation to >=30% of the bone marrow and/or radiation within 4 weeks prior to enrollment
  • Acute or chronic hepatitis
  • Known HIV infection
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms
  • A history of additional risk factors for Torsade de Pointes (e.g., heart failure hypokalemia, family history of Long QT Syndrome)

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Vinflunine
solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Response Rate (RR: Complete Response [CR]+Partial Response [PR], as defined by Response Evaluation Criteria in Solid Tumors [RECIST]
Time Frame: throughout the study
throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimation of the progression free survival and overall survival
Time Frame: At the end of the study
At the end of the study
The estimation of the disease control rate
Time Frame: At the end of the study
At the end of the study
The time to response and the duration of response
Time Frame: At the end of the study
At the end of the study
The evaluation of the safety profile of vinflunine
Time Frame: At the end of the study
At the end of the study

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

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, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

August 1, 2006

First Submitted That Met QC Criteria

August 1, 2006

First Posted (Estimate)

August 2, 2006

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 27, 2010

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA183-023

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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