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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Medical Monitor, MD

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3128K1-201

NCT ID:

NCT00063219

Start Date:

Completion Date:

February 2005

Related Keywords:

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

Name

Location

Alexandria, Minnesota  56308
Fountain Valley, California  92708
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Louisville, Kentucky  40207
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Charleston, South Carolina