Status:
COMPLETED
Study of Dalotuzumab Alone and With Ridaforolimus in Pediatric Participants With Advanced Solid Tumors (MK-8669-062 AM1)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Solid Tumors
Eligibility:
All Genders
3-17 years
Phase:
PHASE1
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 ma...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Participants of age 3 to 17 years for Part 1 of the study and age 6 to 17 years for Parts 2 and 3 of the study
- Histologic or cytologic diagnosis of a malignant solid tumor, including tumors of the central nervous system and lymphoma, that have progressed despite standard therapy or for which no effective standard therapy is known.
- Measurable or non-measurable disease for Parts 1 and 2; measurable disease for Part 3
- Parts 2 and 3: must be able to swallow tablets
- Performance Status: Lansky Play Scale ≥70 for children \<10 years of age; Karnofsky score ≥70 for children ≥10 to \<16 years; or Eastern Cooperative Oncology Group (ECOG) Status 0-2 for patients age 16 and older
- Adequate organ function
- For females of reproductive potential, a negative pregnancy test must be documented within 72 hours of receiving the first dose of study medication
- Participants of reproductive potential must agree to use (or have their partner use) adequate contraception throughout the study, starting with Visit 1 through 30 days after the last dose of study drug
- Exclusion criteria:
- Currently receiving any other investigational agents or using any investigational devices
- Leukemia
- Previously received dalotuzumab or other IGF-1R inhibitors for Part 1
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to dalotuzumab or ridaforolimus
- Persistent acute toxicity from previous therapy ≥Grade 2 (excluding alopecia, neuropathy, or hearing loss)
- Uncontrolled intercurrent illness despite adequate therapy
- Pregnant or breastfeeding
- For Parts 2 and 3: requirement for concurrent treatment with medications that are inducers or inhibitors of cytochrome P450 (CYP3A)
- Poorly controlled Type 1 or 2 diabetes
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01431547
Start Date
February 1 2012
End Date
September 1 2013
Last Update
June 17 2016
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