Study of SU011248 in Patients with Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to test whether SU011248 has activity and is safe in patients with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing regimen and docetaxel.

Official Title

A Phase 2 Efficacy and Safety Study of SU011248 in Patients with Metastatic Non-Small Cell Lung Cancer

Conditions

Non-Small-Cell Lung Carcinoma

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Details

Study Start

September 2004

Eligibility & Criteria

Inclusion Criteria:- Histologically confirmed advanced or metastatic Non-Small Cell Lung Cancer that cannot be cured with surgery, radiation, or combination thereof – No more than 2 prior chemotherapy treatments including treatment with a platinum containing therapy – Evidence of measurable disease by radiographic technique – Male or Female, 18 years or older – ECOG performance status of 0 or 1 – Resolution of all acute toxicities of prior therapies – Adequate organ function – No major surgery or radiation therapy within 4 weeks – No severe hemorrhage within 4 weeks – No previous treatment with anti-angiogenesis agents – No diagnosis of second malignancy within last five 5 years – No history of or known brain metastases, spinal cord compression, or carcinomatous meningitis – No known HIV – No serious acute or chronic illness – No current treatment on another clinical trial – Not pregnant or breastfeeding

Total Enrolment

60

Contact Details

SU011248 Clinical Trial Information Service: 1-877-416-6248 Pfizer