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A Study of OSI-7904L as Treatment in Patients With Head and Neck Cancer Who Have Failed First-Line Therapy

This study has been completed.
Sponsor:
Information provided by:
OSI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00116909
First received: June 30, 2005
Last updated: March 13, 2007
Last verified: March 2007

June 30, 2005
March 13, 2007
August 2004
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Complete list of historical versions of study NCT00116909 on ClinicalTrials.gov Archive Site
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A Study of OSI-7904L as Treatment in Patients With Head and Neck Cancer Who Have Failed First-Line Therapy
A Phase II Study of Single-Agent OSI-7904L in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Failed First-Line Therapy

Multi-center, Phase II study to evaluate the efficacy and safety of OSI-7904Lin head and neck cancer in patients who have failed first-line therapy

Not Provided
Interventional
Phase 2
Primary Purpose: Treatment
  • Locally Recurrent or Metastatic Cancer of the Head and Neck
  • Must Have Failed First-Line Therapy
Drug: OSI 7904L
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
August 2005
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Inclusion Criteria:

Histologically or cytologically confirmed metastatic or locally recurrent SCCHN that is incurable with surgery or radiation therapy ECOG performance status 0-2 No more tha 1 prior chemotharapy regimen for metastatic or locally recurrent disease Adequate bone marrow, Hepatic and renal function. At least one target lesion greater than or equal to 20 mm.

Exclusion Criteria:

Symptomatic brain metasteses which are not stable, are not adequately controlled, are potenially life threatening or required radiation in the last 28 days Pregnant or lactating women. Concurrent anticancer therapy or other investigational drugs Patients with active or uncontrolled infections or other serious illnesses or medical conditions.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00116909
OSI-904-203
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OSI Pharmaceuticals
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Not Provided
OSI Pharmaceuticals
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP