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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 21, 2005 | ||||
| Last Updated Date | April 2, 2009 | ||||
| Start Date ICMJE | July 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Quality of Life | ||||
| Original Primary Outcome Measures ICMJE |
*Quality of Life | ||||
| Change History | Complete list of historical versions of study NCT00115206 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Quality of Life, *Neutropenia, *Hospitalization, *Disease Response | ||||
| Original Secondary Outcome Measures ICMJE |
*Quality of Life, *Neutropenia, *Hospitalization, *Disease Response | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neulasta® in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) During Chemotherapy | ||||
| Official Title ICMJE | A Pilot Study of the Effects of Neutropenia on Patient Reported Outcomes During Chemotherapy With or Without Neulasta® (Pegfilgrastim) in Subjects With Advanced NSCLC | ||||
| Brief Summary | The purpose of this study is to estimate the relationship between patient reported outcomes (PROs) and neutropenia (or its complications) in NSCLC subjects receiving chemotherapy with or without Neulasta® (pegfilgrastim). |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Non-Small Cell Lung Cancer | ||||
| Intervention ICMJE | Drug: Neulasta® (pegfilgrastim) | ||||
| 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 | July 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Non-small cell lung cancer, not previously treated with chemotherapy or radiotherapy - ECOG performance status 0 or 1 - ANC greater than or equal to 2.0 x 10^9/L Exclusion Criteria: - Cancer other than NSCLC within 5 years of enrollment, with the exception of surgically cured basal cell carcinoma or in situ carcinoma of the cervix - Treatment less than or equal to 30 days prior with any experimental agent - Subjects with symptomatic brain metastases - Subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving other investigational agent(s) |
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| 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 | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00115206 | ||||
| Responsible Party | Global Development Leader, Amgen Inc. | ||||
| Study ID Numbers ICMJE | 20020121 | ||||
| Study Sponsor ICMJE | Amgen | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Amgen | ||||
| Verification Date | April 2009 | ||||
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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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