Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases

Pfizer

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00372775

A6181092

Details and patient eligibility

About

This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with radiologically proven brain metastases secondary to non-small cell lung cancer
• Received previous whole brain radiation therapy and none, 1 or 2 prior systemic therapy for the treatment of advanced/metastatic non-small cell lung cancer

Exclusion criteria

• Patients with brainstem lesions, spinal cord compression. carcinomatous meningitis, or leptomeningeal disease.
• Brain metastases >4 cm in any linear direction
• Intracranial or intratumoral hemorrhage

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Sunitinib

Experimental group

Treatment:

Drug: Sunitinib