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

August 20, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0098
    • Maryland
      • Baltimore, Maryland, United States, 21231-1000
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • New York
      • New York, New York, United States, 10032
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
    • Ohio
      • Cleveland, Ohio, United States, 44195
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
      • Pittsburgh, Pennsylvania, United States, 15213
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

February 1, 2005

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

June 23, 2003

First Submitted That Met QC Criteria

June 24, 2003

First Posted (Estimate)

June 25, 2003

Study Record Updates

Last Update Posted (Estimate)

August 21, 2009

Last Update Submitted That Met QC Criteria

August 20, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3128K1-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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