NCT00063219

Study Evaluating MAC-321 in Non-small Cell Lung Cancer Refractory to Platinum-based Therapy

A Phase 2, Open-label Study of MAC-321 Administered Intravenously as a Single Agent for the Treatment of Non-small Cell Lung Cancer Refractory to Platinum-based Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This non-randomized, open-label clinical trial is designed to determine safety and clinical activity of a new chemotherapeutic agent, MAC-321, when given intravenously to patients with non-small cell lung cancer. Clinical activity will be evaluated by determining the percentage of patients with an objective tumor response after treatment with MAC-321. Patients must have been previously treated with a platinum-containing chemotherapy regimen. A total of 96 patients will be enrolled in this trial. Eligible patients will receive MAC-321 intravenously every 3 weeks for up to a total of 6 courses of treatment. All patients will receive MAC-321 at the same dose. MAC-321 is an experimental drug, and is not offered outside of this research trial.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Interventions

Type	Name	Description
DRUG	MAC-321

Timeline

• Primary completion: 2005-02-01
• Completion: 2005-02-01
• First posted: 2003-06-25
• Last updated: 2009-08-21

Locations

13 sites across 1 country: United States