Study Evaluating MAC-321 in Non-small Cell Lung Cancer Refractory to Platinum-based Therapy
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
1 other identifier
interventional
48
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2003
CompletedFirst Posted
Study publicly available on registry
June 25, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedAugust 21, 2009
August 1, 2009
June 23, 2003
August 20, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Los Angeles, California, 90033, United States
Unknown Facility
Lexington, Kentucky, 40536-0098, United States
Unknown Facility
Baltimore, Maryland, 21231-1000, United States
Unknown Facility
Worcester, Massachusetts, 01655, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
Charlotte, North Carolina, 28203, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Philadelphia, Pennsylvania, 19140, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor, MD
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 23, 2003
First Posted
June 25, 2003
Primary Completion
February 1, 2005
Study Completion
February 1, 2005
Last Updated
August 21, 2009
Record last verified: 2009-08