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

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

In brief

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.

Key facts

Study ID

NCT00063219

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

48

Expected to finish

2005-02-01

Last updated by the study team

2009-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recurrence of non-small cell lung cancer after at least 1 prior chemotherapy regimen containing a platinum agent
• Recovery from all acute side effects of prior therapies (with the exception of hair loss)
• Adequate bone marrow, liver, and kidney function

You may not qualify if…

• More than 2 prior chemotherapy regimens for treatment of advanced or metastatic non-small cell lung cancer. (Treatment given in conjunction with surgery will not be included in the maximum of 2 prior regimens)
• Radiation therapy, chemotherapy or any other anticancer therapy within 28 days of beginning study
• Symptomatic brain metastases

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Lexington, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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