Study Evaluating MAC-321 in Non-small Cell Lung Cancer Refractory to Platinum-based Therapy
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00063219
First received: June 23, 2003
Last updated: August 20, 2009
Last verified: August 2009
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063219
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 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor, MD | Wyeth is now a wholly owned subsidiary of Pfizer |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00063219 History of Changes |
| Other Study ID Numbers: | 3128K1-201 |
| Study First Received: | June 23, 2003 |
| Last Updated: | August 20, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Non-Small-Cell Lung Carcinoma Lung Cancer Cancer of Lung |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic |
Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013