Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

OSI-7904L

Drug
Who is being recruted

Gastroesophageal Adenocarcinoma

+ Gastric Adenocarcinoma
Over 18 Years
+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2003

See protocol details

Summary

Principal SponsorOSI Pharmaceuticals
Last updated: February 22, 2006
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleA Phase II Study of Single Agent OSI-7904L In Patients With Locally Advanced or Metastatic Adenocarcinoma Of the Stomach or Gastroesophageal Junction 
Principal SponsorOSI Pharmaceuticals
Last updated: February 22, 2006
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
43 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Gastroesophageal Adenocarcinoma
Gastric Adenocarcinoma
Criteria
1 inclusion criteria required to participate
ocumented 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
1 exclusion criteria prevent from participating
ctive or uncontrolled infections or other serious illnesses or other medical conditions (eg, hepatitis, HIV, chronic alcohol abuse) Symptomatic brain metastases which are not stable

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 11 locations
Suspended
University of Pennsylvania Cancer CenterPhiladelphia, United StatesSee the location
Suspended
MD Anderson Cancer CenterHouston, United States
Suspended
University of Utah, Huntsman Cancer InstituteSalt Lake City, United States
Suspended
Dept Internal Medicine Gastrointestinal Oncology UnitB-3000 Leuven, Belgium
Completed11 Study Centers