Study Evaluating MAC-321 in Non-small Cell Lung Cancer Refractory to Platinum-based Therapy
NCT00063219
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Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating MAC-321 in Non-small Cell Lung Cancer Refractory to Platinum-based Therapy | |||
| Official Title ICMJE | 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 | |||
| Brief 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: MAC-321 | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 48 | |||
| Original Enrollment ICMJE | Not Provided | |||
| Actual Study Completion Date ICMJE | February 2005 | |||
| Actual Primary Completion Date | February 2005 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00063219 | |||
| Other Study ID Numbers ICMJE | 3128K1-201 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | August 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||