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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
5mg or 10mg po daily
16mg/kg iv every 3 weeks
Unnamed facility
New York, New York, United States
Unnamed facility
San Antonio, Texas, United States
Unnamed facility
Milan, Lombardy, Italy
Maximum tolerated dose of RAD001, in combination with R1507 (Part 1
Time frame: First 3 week cycle of treatment
Progression-free survival (Part 2)
Time frame: 24 weeks
Overall objective response rate; duration of response; overall survival
Time frame: Event driven; monitored throughout study
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