Status:
TERMINATED
A Study of Ridaforolimus in Pediatric Participants With Advanced Solid Tumors (MK-8669-056)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Solid Tumors
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
Brief Summary
The main objectives of this trial are to determine the recommended dose of ridaforolimus for pediatric participants with advanced solid tumors by measuring the number of participants experiencing dose...
Eligibility Criteria
Inclusion
- 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. Participants 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
Exclusion
Key Trial Info
Start Date :
January 30 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01431534
Start Date
January 30 2012
End Date
May 25 2018
Last Update
March 1 2019
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