A Study of Vinflunine in Patients With Gastric Cancer - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00359476

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 II Phase III

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Vinflunine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Multicenter, Single-Arm, Phase II Study of Single-Agent Vinflunine in the Second-Line Treatment of Patients With Gastric Cancer

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

Arms	Assigned Interventions
1: Experimental	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359476

Locations

Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 120-752
Local Institution
Seoul, Korea, Republic of, 136-705
Local Institution
Gyeonggi-Do, Korea, Republic of, 410-769
Korea, Republic of, Gyeonggi-Do
Local Institution
Suwon-Si, Gyeonggi-Do, Korea, Republic of, 442-723
Malaysia, Negeri Sembilan
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

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA183-023
Study First Received:	August 1, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00359476
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

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases

Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Adenocarcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009