A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
Tracking Information
Start Date ICMJE | |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: May 7, 2008) |
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Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00674973 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 7, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer |
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Official Title ICMJE | A Randomized, Double Blind Study of Biomarkers Predictive of Improvement in Progression Free Survival in Patients With Advanced Pancreatic Cancer Treated With Tarceva. |
Brief Summary | This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Pancreatic Cancer |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Recruitment Status ICMJE | Recruiting | ||||||||
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Estimated Enrollment ICMJE | 252 | ||||||||
Estimated Completion Date | September 2010 | ||||||||
Primary Completion Date | |||||||||
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 | Argentina, Australia, Brazil, Bulgaria, Croatia, France, Germany, Hong Kong, India, Italy, Latvia, Lithuania, Malaysia, Mexico, Peru, Romania, Russian Federation, Singapore, Slovenia, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00674973 | ||||
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Responsible Party | Clinical Trials, Study Director, Hoffmann-La Roche | ||||
Study ID Numbers ICMJE | BO21129, 2007-003738-40 | ||||
Study Sponsor ICMJE | Hoffmann-La Roche | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Hoffmann-La Roche |
Source: http://clinicaltrials.gov/