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A Study of Vinflunine in Patients With Gastric Cancer

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00359476
First received: August 1, 2006
Last updated: February 27, 2010
Last verified: December 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00359476     History of Changes
Other Study ID Numbers: CA183-023
Study First Received: August 1, 2006
Last Updated: February 27, 2010
Health Authority: United States: Food and Drug Administration
Korea: Korean Food and Drug Administration

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

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on November 23, 2014