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A Study of Vinflunine in Patients With Gastric Cancer

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00359476
First Posted: August 2, 2006
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
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.

Condition Intervention Phase
Stomach Cancer Drug: Vinflunine Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single-Arm, Phase II Study of Single-Agent Vinflunine in the Second-line Treatment of Patients With Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 55
Study Start Date: March 2007
Study Completion Date: November 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Vinflunine
solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359476


Locations
Korea, Republic of
Local Institution
Suwon-Si, Gyeonggi-Do, Korea, Republic of, 442-723
Local Institution
Gyeonggi-Do, Korea, Republic of, 410-769
Local Institution
Seoul, Korea, Republic of, 120-752
Local Institution
Seoul, Korea, Republic of, 136-705
Malaysia
Local Institution
Nilai, Negeri Sembilan, Malaysia, 71800
Philippines
Local Institution
Quezon City, Philippines, 1102
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00359476     History of Changes
Other Study ID Numbers: CA183-023
First Submitted: August 1, 2006
First Posted: August 2, 2006
Last Update Posted: March 2, 2010
Last Verified: December 2007

Keywords provided by Bristol-Myers Squibb:
Locally advanced/metastatic gastric adenocarcinoma
adenocarcinoma-gastroesophageal junction
Gastric Adenocarcinoma

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Vinblastine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action


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