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

This study has been completed.
Sponsor:
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
  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:

Enrollment: 48
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014