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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Stomach Cancer

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Response Rate (RR: Complete Response [CR]+Partial Response [PR], as defined by Response Evaluation Criteria in Solid Tumors [RECIST]

Outcome Time Frame:

throughout the study

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA183-023

NCT ID:

NCT00359476

Start Date:

March 2007

Completion Date:

November 2007

Related Keywords:

  • Stomach Cancer
  • Locally advanced/metastatic gastric adenocarcinoma
  • adenocarcinoma-gastroesophageal junction
  • Gastric Adenocarcinoma
  • Stomach Neoplasms

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