- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00116896
Phase I Study of Cisplatin Plus OSI-7904L in Patients With Solid Tumors
January 16, 2009 updated by: OSI Pharmaceuticals
Phase I Study of OSI-7904L in Combination With Cisplatin in Patients With Advanced Solid Tumors
This is a Phase I, open-label, dose escalation, study of the combination of cisplatin and OSI-7904L given on Day 1 every 21 days in patient who have advanced solid tumors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
25
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232-6307
- Vanderbilt Universtiy Medical Center
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Texas
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San Antonio, Texas, United States, 78229
- Institute for Drug DevelopmentCancer Therapy & Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older
- Advanced and/or metastatic solid tumor for which no effective therapy is available
- ECOG performance status 0-2
- Adequate bone marrow, hepatic and renal function
Exclusion Criteria:
- Patients with active or uncontrolled infections
- Neurotoxicity >= Grade 2
- Symptomatic brain metastases which are not stable
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Study Completion
December 1, 2004
Study Registration Dates
First Submitted
June 30, 2005
First Submitted That Met QC Criteria
June 30, 2005
First Posted (Estimate)
July 1, 2005
Study Record Updates
Last Update Posted (Estimate)
January 21, 2009
Last Update Submitted That Met QC Criteria
January 16, 2009
Last Verified
November 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSI-904-102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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