Study of Dalotuzumab Alone and With Ridaforolimus in Pediatric Participants With Advanced Solid Tumors (MK-8669-062 AM1)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: September 9, 2011
Last Update Posted: June 17, 2016
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This is a study of dalotuzumab given as monotherapy and in combination with ridaforolimus for pediatric participants with advanced solid tumors. This study will have three parts. Part 1 will find a maximum tolerated dose (MTD) and collect pharmacokinetic (PK) data for dalotuzumab alone. Part 2 will find an MTD and collect PK data for dalotuzumab in combination with ridaforolimus. Part 3 will be an expansion cohort at the recommended Phase 2 dose (RPTD) found in Part 2 to confirm the RPTD and look at the potential efficacy of the combination therapy.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Monotherapy Dalotuzumab and Ridaforolimus-Dalotuzumab Combination Treatment in Pediatric Patients With Advanced Solid Tumors|
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Number of participants with dose limiting toxicities (DLTs) while receiving dalotuzumab alone [ Time Frame: First 21 days of treatment ]
- Number of participants with DLTs while receiving dalotuzumab and ridaforolimus combination therapy [ Time Frame: First 21 days of treatment ]
- Dalotuzumab mean serum trough concentration [ Time Frame: Day 22, pre-dose (Part 1) ]
- Dalotuzumab mean serum trough concentration in combination therapy [ Time Frame: Day 22, pre-dose (Part 2) ]
- Ridaforolimus geometric mean area under the concentration curve from Hour 0 to Hour 24 (AUC [0-24]) in combination therapy [ Time Frame: Cycle 1, Day 5 (Part 2) ]
|Study Start Date:||February 2012|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Experimental: Part 1: 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
|Experimental: Parts 2 and 3: Dalotuzumab + ridaforolimus||
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 2Drug: 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
Other Name: MK-8669
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