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

NCT ID: NCT00063219

Last Updated: 2009-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung Lung Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MAC-321

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Los Angeles, California, United States

Site Status

Lexington, Kentucky, United States

Site Status

Baltimore, Maryland, United States

Site Status

Worcester, Massachusetts, United States

Site Status

Minneapolis, Minnesota, United States

Site Status

St Louis, Missouri, United States

Site Status

New York, New York, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Cleveland, Ohio, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Charleston, South Carolina, United States

Site Status

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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3128K1-201

Identifier Type: -

Identifier Source: org_study_id

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