Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
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ClinicalTrials.gov Identifier: NCT01192243 |
Recruitment Status : Unknown
Verified September 2010 by Fudan University.
Recruitment status was: Recruiting
First Posted : September 1, 2010
Last Update Posted : September 3, 2010
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Sponsor:
Fudan University
Information provided by:
Fudan University
Tracking Information | ||||
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First Submitted Date ICMJE | August 4, 2010 | |||
First Posted Date ICMJE | September 1, 2010 | |||
Last Update Posted Date | September 3, 2010 | |||
Study Start Date ICMJE | December 2009 | |||
Estimated Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
response rate [ Time Frame: six weeks ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients | |||
Official Title ICMJE | Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small | |||
Brief Summary | The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
68 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | Not Provided | |||
Estimated Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
leucocyte≥ 4×109/L neutrophil≥ 1.5×109/L platelet≥100×109/L Hemoglobin≥ 10g/L ALT and AST ≤2.5×ULN (≤5×ULN if liver metastasis) Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (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 | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01192243 | |||
Other Study ID Numbers ICMJE | Iressa combined with Pem/Cis | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital | |||
Study Sponsor ICMJE | Fudan University | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Fudan University | |||
Verification Date | September 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |