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

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NCT00063219

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Los Angeles, California, 90033 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma, Lung Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00063219
Pfizer
Completed
Study Evaluating MAC-321 in Non-small Cell Lung Cancer Refractory to Platinum-based Therapy

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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

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
Drug: MAC-321
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
February 2005
February 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00063219
3128K1-201
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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