Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer (NSCLC)
Tracking Information
Start Date ICMJE | May 2008 |
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Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: May 5, 2008) | Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00673049 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 5, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer |
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Official Title ICMJE | Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology |
Brief Summary | The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS). |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 600 | ||||||||
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Estimated Completion Date | June 2011 | ||||||||
Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, France, Greece, Hungary, Indonesia, Ireland, Italy, Korea, Republic of, Latvia, Poland, Puerto Rico, Romania, Russian Federation, Serbia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00673049 | ||||
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Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc | ||||
Study ID Numbers ICMJE | A4021018 | ||||
Study Sponsor ICMJE | Pfizer | ||||
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Investigators ICMJE |
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Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/