Study of Dalotuzumab Alone and With Ridaforolimus in Pediatric Participants With Advanced Solid Tumors (MK-8669-062 AM1)

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

Conditions
Solid Tumors
Interventions
DRUG

dalotuzumab

For Part 1: dalotuzumab, intravenously (IV) over 60 minutes every three weeks, dose based on participant body surface area (BSA), starting dose of 900 mg/m\^2, and escalated for successive cohorts of participants until MTD is found

DRUG

dalotuzumab

For Part 2: dalotuzumab IV over 60 minutes every three weeks, dose based on participant BSA, starting at the lowest tolerated dose that met PK target levels in Part 1. For Part 3: dalotuzumab IV over 60 minutes every three weeks, dose based on participant BSA, at the dose level identified for combination therapy in Part 2

DRUG

ridaforolimus

For Part 2: ridaforolimus 10 mg enteric coated tablets, orally, on 5 consecutive days each week, dose based on participant BSA, at 1 dose level lower than the MTD or highest dose level used in the companion study MK-8669-056. For Part 3:ridaforolimus 10 mg enteric coated tablets, orally, on 5 consecutive days each week, dose based on participant BSA, at the dose level identified for combination therapy in Part 2

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01431547 - Study of Dalotuzumab Alone and With Ridaforolimus in Pediatric Participants With Advanced Solid Tumors (MK-8669-062 AM1) | Biotech Hunter | Biotech Hunter