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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Solid Tumors

Treatments

Drug: ridaforolimus

Drug: dalotuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01431547

8669-062

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

3 to 17 years old

Volunteers

No Healthy Volunteers

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