Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC) (GRANITE-1)
Tracking Information
Start Date ICMJE | June 2009 |
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Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: April 9, 2009) | Compare Overall Survival in RAD vs. Placebo group [ Time Frame: 2.5 years ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00879333 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: April 9, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC) |
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Official Title ICMJE | A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy |
Brief Summary | This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Condition ICMJE | Advanced Gastric Cancer |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 633 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply | ||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Belgium, Brazil, Canada, Colombia, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Russian Federation, Taiwan, Thailand, United Kingdom, Venezuela |
Administrative Information
NCT ID ICMJE | NCT00879333 | ||||
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Responsible Party | External Affairs, Novartis Pharmaceuticals | ||||
Study ID Numbers ICMJE | CRAD001R2301, EUDRACT No. - 2008-006544-20 | ||||
Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Novartis |
Source: http://clinicaltrials.gov/