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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00063219
Recruitment Status : Completed
First Posted : June 25, 2003
Last Update Posted : August 21, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.


Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Drug: MAC-321 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Masking: None (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
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063219


Locations
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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
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Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
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ClinicalTrials.gov Identifier: NCT00063219    
Other Study ID Numbers: 3128K1-201
First Posted: June 25, 2003    Key Record Dates
Last Update Posted: August 21, 2009
Last Verified: August 2009
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:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms