A Study of Ridaforolimus in Pediatric Patients With Advanced Solid Tumors (MK-8669-056)
This is a study to find a maximum tolerated dose (MTD) and pharmacokinetic (PK) data for ridaforolimus given to participants between the ages of 6 and 17 years with advanced solid tumors.
Study-related visits concluded in August 2013. Participants may continue treatment until they meet discontinuation criteria or voluntarily withdraw.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Ridaforolimus in Pediatric Patients With Advanced Solid Tumors|
- Number of participants with dose limiting toxicities (DLTs) [ Time Frame: First 28-day cycle ]
- Ridaforolimus geometric mean area under the concentration curve from hour 0 to hour 24 (AUC0-24). [ Time Frame: Cycle 1, Day 5 ]
|Actual Study Start Date:||January 30, 2012|
|Estimated Study Completion Date:||September 21, 2017|
|Primary Completion Date:||August 20, 2013 (Final data collection date for primary outcome measure)|
Ridaforolimus supplied as 10 mg enteric-coated tablets, orally, at escalating doses starting at 22 mg/m^2 based on body surface area (BSA), for 5 consecutive days each week in consecutive 28-day cycles
Other Name: MK-8669
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