Study of Dalotuzumab Alone and With Ridaforolimus in Pediatric Participants With Advanced Solid Tumors (MK-8669-062 AM1)
- Registration Number
- NCT01431547
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Parts 2 and 3: Dalotuzumab + ridaforolimus dalotuzumab - Parts 2 and 3: Dalotuzumab + ridaforolimus ridaforolimus - Part 1: Dalotuzumab dalotuzumab -
- Primary Outcome Measures
Name Time Method Number of participants with DLTs while receiving dalotuzumab and ridaforolimus combination therapy First 21 days of treatment Number of participants with dose limiting toxicities (DLTs) while receiving dalotuzumab alone First 21 days of treatment Dalotuzumab mean serum trough concentration Day 22, pre-dose (Part 1) Dalotuzumab mean serum trough concentration in combination therapy 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 Cycle 1, Day 5 (Part 2)
- Secondary Outcome Measures
Name Time Method