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

NCT ID: NCT00073502

Last Updated: 2006-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2003-10-31

Brief Summary

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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 may be switched to a commonly used combination regimen.

Detailed Description

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Conditions

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Gastroesophageal Adenocarcinoma Gastric Adenocarcinoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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OSI-7904L

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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 Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OSI Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Dept Internal Medicine Gastrointestinal Oncology Unit

B-3000 Leuven, , Belgium

Site Status

Bristol Haematology & Oncology Centre

Bristol, Avon, United Kingdom

Site Status

ICRF Medical Oncology Unit

Oxford, Oxfordshire, United Kingdom

Site Status

Deanesly Centre

Wolverhampton, West Midlands, United Kingdom

Site Status

NICCTU, East Podium, C-Floor

Belfast, , United Kingdom

Site Status

Beatson Oncology Centre

Glasgow, , United Kingdom

Site Status

Cookridge Hospital

Leeds, , United Kingdom

Site Status

Department of Medical Oncology

Manchester, , United Kingdom

Site Status

Countries

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United States Belgium United Kingdom

Other Identifiers

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OSI-904-201

Identifier Type: -

Identifier Source: org_study_id