Phase I Study of Cisplatin Plus OSI-7904L in Patients With Solid Tumors

This study has been completed.

First Received: June 30, 2005 Last Updated: January 16, 2009 History of Changes

Sponsored by:	OSI Pharmaceuticals
Information provided by:	OSI Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00116896

Purpose

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.

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: OSI-7904L Drug: Cisplatin	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase I Study of OSI-7904L in Combination With Cisplatin in Patients With Advanced Solid Tumors

Further study details as provided by OSI Pharmaceuticals:

Estimated Enrollment:	25
Study Start Date:	June 2003
Estimated Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116896

Locations

United States, Tennessee
Vanderbilt Universtiy Medical Center
Nashville, Tennessee, United States, 37232-6307
United States, Texas
Institute for Drug DevelopmentCancer Therapy & Research Center
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

OSI Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	OSI-904-102
Study First Received:	June 30, 2005
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00116896 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Radiation-Sensitizing Agents
Cisplatin

Additional relevant MeSH terms:

Radiation-Sensitizing Agents
Cisplatin
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009