Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092001

A6181040

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Major surgery or radiation therapy within 4 weeks
• Severe hemorrhage within 4 weeks
• Previous treatment with anti-angiogenesis agents
• Diagnosis of second malignancy within last five 5 years
• History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
• Known HIV
• Serious acute or chronic illness
• Current treatment on another clinical trial
• Pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Sunitinib