Tracking Information
Start Date ICMJE | November 2009 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: September 25, 2009) |
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Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00985374 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: October 15, 2009) | Overall objective response rate; duration of response; overall survival [ Time Frame: Event driven; monitored throughout study ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE (submitted: September 25, 2009) |
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Descriptive Information
Brief Title ICMJE | A Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors |
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Official Title ICMJE | Multiple Ascending Dose (MAD) Phase Ib/II Study of the mTOR Inhibitor (RAD001) in Combination With the IGF-1R Antagonist (R1507) for the Treatment of Patients With Advanced Solid Tumors |
Brief Summary | This 2 part study will assess the safety, tolerability and efficacy of a combination of oral daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1 of the study, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001 daily + 16mg/kg intravenous (iv) R1507 every 3 weeks (level 1) and if tolerated, 10mg po RAD001 daily + 16mg/kg iv R1507 every 3 weeks (level 2).In Part 2 of the study, patients with 1) advanced renal cell cancer and 2) advanced pancreatic neuroendocrine tumors will receive the maximum tolerated dose regimen from Part 1 (5mg or 10mg po RAD001 + 16mg/kg iv R1507). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. |
Detailed Description | |
Study Phase | Phase I |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Condition ICMJE | Neoplasms |
Intervention ICMJE |
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Study Arms / Comparison Groups | 1: Experimental Interventions:
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Recruitment Information
Estimated Enrollment ICMJE | 144 | ||||
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Estimated Completion Date | October 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 | United States, Brazil, Italy, Russian Federation, Spain |
Administrative Information
NCT ID ICMJE | NCT00985374 | ||||
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Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
Study ID Numbers ICMJE | NO21884, 2008-005806-38 | ||||
Study Sponsor ICMJE | Hoffmann-La Roche | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Hoffmann-La Roche |