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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00116909

Enrollment

Registered

2005-07-01

Start date

2004-08-31

Completion date

2005-08-31

Last updated

2007-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

DRUGOSI 7904L

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026