|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00063219 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms |
Drug: MAC-321 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label |
| Official Title: | 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Los Angeles, California, United States, 90033 | |
| United States, Kentucky | |
| Lexington, Kentucky, United States, 40536-0098 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21231-1000 | |
| United States, Massachusetts | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37232 | |
| Study Director: | Medical Monitor, MD | Wyeth |
More Information
| Study ID Numbers: | 3128K1-201 |
| Study First Received: | June 23, 2003 |
| Last Updated: | May 18, 2006 |
| ClinicalTrials.gov Identifier: | NCT00063219 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Non-Small-Cell Lung Carcinoma Lung Cancer Cancer of Lung |
|
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
