A Study of OSI-7904L as Treatment in Patients With Head and Neck Cancer 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

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Key information

Conditions

Locally Recurrent or Metastatic Cancer of the Head and Neck Head and Neck Neoplasms Must Have Failed First-Line Therapy Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OSI 7904L

Drug

Sponsors and collaborators

Lead sponsor

OSI Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Study completion: 2005
First posted: Jul 1, 2005
Registry last updated: Mar 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed