This trial is active, not recruiting.

Condition solid tumors
Treatment ridaforolimus
Phase phase 1
Sponsor Merck Sharp & Dohme Corp.
Start date January 2012
End date August 2013
Trial size 21 participants
Trial identifier NCT01431534, 8669-056


This is a study to find a maximum tolerated dose (MTD) and pharmacokinetic (PK) data for ridaforolimus given to participants between the ages of 6 and 17 years with advanced solid tumors.

Study-related visits concluded in August 2013. Participants may continue treatment until they meet discontinuation criteria or voluntarily withdraw.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
ridaforolimus MK-8669
Ridaforolimus supplied as 10 mg enteric-coated tablets, orally, at escalating doses starting at 22 mg/m^2 based on body surface area (BSA), for 5 consecutive days each week in consecutive 28-day cycles

Primary Outcomes

Number of participants with dose limiting toxicities (DLTs)
time frame: First 28-day cycle
Ridaforolimus geometric mean area under the concentration curve from hour 0 to hour 24 (AUC0-24).
time frame: Cycle 1, Day 5

Eligibility Criteria

Male or female participants from 6 years up to 17 years old.

Inclusion criteria: - 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. Patients who have received standard therapy and continue to have biopsy-proven residual stable disease are eligible - Measurable or non-measurable disease - 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 - Participant previously received ridaforolimus, rapamycin, or other rapamycin analogs - History of allergic reactions attributed to compounds of similar chemical or biologic composition to ridaforolimus - Persistent acute toxicity from previous therapy ≥Grade 2 (excluding alopecia, neuropathy, or hearing loss) - Uncontrolled intercurrent illness despite adequate therapy - Pregnant or breastfeeding - Requirement for concurrent treatment with medications that are inducers or inhibitors of cytochrome P450 (CYP3A) - Poorly controlled Type 1 or 2 diabetes

Additional Information

Official title A Phase I Study of Ridaforolimus in Pediatric Patients With Advanced Solid Tumors
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..