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

This study has been completed.
Sponsor:
Information provided by:
OSI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00116896
First received: June 30, 2005
Last updated: January 16, 2009
Last verified: November 2003
History of Changes
  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 1

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin
U.S. FDA Resources

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

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

Additional relevant MeSH terms:
Neoplasms
Cisplatin
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013