Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma
Tracking Information
tart Date ICMJE | May 2009 |
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Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: May 13, 2009) | Overall Survival measured via patient phone contacts after treatment is complete [ Time Frame: From the date of randomization until th date of death due to any cause ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00901901 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 13, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma |
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Official Title ICMJE | A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC) |
Brief Summary | This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Carcinoma, Hepatocellular |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 700 | ||||||||
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Estimated Completion Date | July 2011 | ||||||||
Estimated Primary Completion Date | July 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, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hong Kong, Israel, Italy, Korea, Republic of, New Zealand, Peru, Poland, Russian Federation, Singapore, South Africa, Spain, Taiwan, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00901901 | ||||
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Responsible Party | Therapeutic Area Head, Bayer Healthcare AG | ||||
Study ID Numbers ICMJE | 12917, EudraCT:2008-006021-14, SEARCH | ||||
Study Sponsor ICMJE | Bayer | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | Bayer |
Source: http://clinicaltrials.gov/