Status:

COMPLETED

Phase II Study of Single Agent OSI-7904L in Patients With Gastric or Gastroesophageal (GEJ) Cancer

Lead Sponsor:

OSI Pharmaceuticals

Conditions:

Gastroesophageal Adenocarcinoma

Gastric Adenocarcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Multi-center, open-label, non-randomized Phase II study to evaluate the efficacy and safety of OSI-7904L in gastric and GEJ cancers. Those patients who do not derive clinical benefit after two cycles ...

Eligibility Criteria

Inclusion

  • Documented locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction No prior chemotherapy for locally advanced or metastatic disease Adequate baseline bone marrow, hepatic and renal function Age \>= 18 years At least one target lesion

Exclusion

  • Active or uncontrolled infections or other serious illnesses or other medical conditions (eg, hepatitis, HIV, chronic alcohol abuse) Symptomatic brain metastases which are not stable

Key Trial Info

Start Date :

October 1 2003

Trial Type :

INTERVENTIONAL

End Date :

October 1 2003

Estimated Enrollment :

43 Patients enrolled

Trial Details

Trial ID

NCT00073502

Start Date

October 1 2003

End Date

October 1 2003

Last Update

February 22 2006

Active Locations (11)

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Page 1 of 3 (11 locations)

1

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States, 19104

2

MD Anderson Cancer Center

Houston, Texas, United States, 77030

3

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

4

Dept Internal Medicine Gastrointestinal Oncology Unit

B-3000 Leuven, Belgium