Study of the Efficacy of an Investigational Drug in Adult Patients With Non Small-Cell Lung Cancer (NSCLC)
NCT00034957
ABOUT THIS STUDY
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Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
Eligible patients must be at least 18 years of age with a diagnosis of NSCLC that has gotten worse during or after treatment with platinum-based chemotherapy. Patients must have at least one tumor that can be evaluated by the doctor during the investigational drug treatment. Any side-effects from prior chemotherapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function.
Any of the following will exclude patients from study participation:
receipt of more than 1 prior regimen of chemotherapy for NSCLC (repeat of the same
chemotherapy at different points in time count as 1 regimen). Irradiation to 25% or more of
bone marrow, prior high dose chemotherapy with bone marrow or stem cell support, current
participation in other clinical trials, pregnant or breast-feeding women, known
HIV-positive or AIDS-related illness.
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | Study of the Efficacy of an Investigational Drug in Adult Patients With Non Small-Cell Lung Cancer (NSCLC) | ||
| Official Title ICMJE | Not Provided | ||
| Brief Summary | The primary goal of the study is to evaluate an investigational drug's effectiveness as a treatment for Non small-cell lung cancer (NSCLC) | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 2 | ||
| Study Design ICMJE | Primary Purpose: Treatment | ||
| Condition ICMJE |
| ||
| Intervention ICMJE | Drug: Investigational drug | ||
| 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 | ||
| Enrollment ICMJE | Not Provided | ||
| Original Enrollment ICMJE | Not Provided | ||
| Actual Study Completion Date ICMJE | October 2002 | ||
| Actual Primary Completion Date | October 2002 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria: Eligible patients must be at least 18 years of age with a diagnosis of NSCLC that has gotten worse during or after treatment with platinum-based chemotherapy. Patients must have at least one tumor that can be evaluated by the doctor during the investigational drug treatment. Any side-effects from prior chemotherapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function. Exclusion Criteria: Any of the following will exclude patients from study participation: receipt of more than 1 prior regimen of chemotherapy for NSCLC (repeat of the same chemotherapy at different points in time count as 1 regimen). Irradiation to 25% or more of bone marrow, prior high dose chemotherapy with bone marrow or stem cell support, current participation in other clinical trials, pregnant or breast-feeding women, known HIV-positive or AIDS-related illness. | ||
| 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 | NCT00034957 | ||
| Other Study ID Numbers ICMJE | 196-ONC-0100-005 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Pfizer | ||
| Study Sponsor ICMJE | Pfizer | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Pfizer | ||
| Verification Date | February 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||