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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on August 19, 2014