NCT00094094

Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer

Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 as Second- or Later- Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 study being conducted at multiple centers in the United States and Germany. Patients having non-small cell lung cancer that has spread to other parts of the body (i.e., metastatic) or is locally advanced (i.e., Stage IIIB with malignant pleural effusion) are eligible to participate. Patients must have disease that has been treated with at least 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for advanced non-small cell lung cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage

Conditions

• Lung Neoplasms
• Carcinoma, Non-small Cell Lung

Interventions

Type	Name	Description
DRUG	axitinib	Axitinib (AG-013736) tablet administered orally at a dose of 5 milligrams (mg) twice daily (BID) in cycles of 4 weeks.

Timeline

• Start date: 2005-02-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2004-10-14
• Last updated: 2012-06-26
• Results posted: 2012-03-16

Locations

11 sites across 2 countries: United States, Germany