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CompletedNCT00063219Updated Aug 21, 2009

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

A Phase 2 interventional study of MAC-321 in Carcinoma, Non-Small-Cell Lung and Lung Neoplasms, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-21.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Keywords

  • Non-Small-Cell Lung Carcinoma
  • Lung Cancer
  • Cancer of Lung
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 48 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Masking
None (open label)
Enrollment
48 participants (actual)

Interventions

  • DrugMAC-321
06

Study locations

13 sites
  • Los Angeles, California 90033, United States
  • Lexington, Kentucky 40536-0098, United States
  • Baltimore, Maryland 21231-1000, United States
  • Worcester, Massachusetts 01655, United States
  • Minneapolis, Minnesota 55455, United States
  • St. Louis, Missouri 63110, United States
  • New York, New York 10032, United States
  • Charlotte, North Carolina 28203, United States
  • Cleveland, Ohio 44195, United States
  • Philadelphia, Pennsylvania 19140, United States
  • Pittsburgh, Pennsylvania 15213, United States
  • Charleston, South Carolina 29425, United States
  • Nashville, Tennessee 37232, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00063219
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Jun 25, 2003
Primary completion
Feb 2005
Completion
Feb 2005
Last update
Aug 21, 2009

Study contacts

Medical Monitor, MD
study director · Wyeth is now a wholly owned subsidiary of Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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