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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 2, 2002 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00034957 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| 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 | |
| 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 | |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment |
| Condition ICMJE |
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| Intervention ICMJE | Drug: Investigational drug |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| 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. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00034957 |
| Responsible Party | |
| Study ID Numbers ICMJE | 196-ONC-0100-005 |
| Study Sponsor ICMJE | Pfizer |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Pfizer |
| Verification Date | March 2004 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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