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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAC-321 | Drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor, MD | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90033 | United States | |||
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| Lexington |
| Kentucky |
| 40536-0098 |
| United States |
| Baltimore | Maryland | 21231-1000 | United States |
| Worcester | Massachusetts | 01655 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| St Louis | Missouri | 63110 | United States |
| New York | New York | 10032 | United States |
| Charlotte | North Carolina | 28203 | United States |
| Cleveland | Ohio | 44195 | United States |
| Philadelphia | Pennsylvania | 19140 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Charleston | South Carolina | 29425 | United States |
| Nashville | Tennessee | 37232 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C479501 | MAC321 |
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