A Study of Ridaforolimus in Pediatric Patients With Advanced Solid Tumors (MK-8669-056)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: September 7, 2011
Last updated: February 16, 2015
Last verified: February 2015
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.
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I Study of Ridaforolimus in Pediatric Patients With Advanced Solid Tumors
Primary Outcome Measures:
- Number of participants with dose limiting toxicities (DLTs) [ Time Frame: First 28-day cycle ] [ Designated as safety issue: Yes ]
- Ridaforolimus geometric mean area under the concentration curve from hour 0 to hour 24 (AUC0-24). [ Time Frame: Cycle 1, Day 5 ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||August 2013 (Final data collection date for primary outcome measure)
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
Other Name: MK-8669
|Ages Eligible for Study:
||6 Years to 17 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- Currently receiving any other investigational agents or using any investigational devices
- 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
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No publications provided
ClinicalTrials.gov processed this record on March 03, 2015
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 7, 2011
||February 16, 2015
||United States: Food and Drug Administration