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A Study of Ridaforolimus in Pediatric Patients With Advanced Solid Tumors (MK-8669-056)

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ClinicalTrials.gov Identifier: NCT01431534
Recruitment Status : Active, not recruiting
First Posted : September 9, 2011
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Solid Tumors Drug: ridaforolimus Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Ridaforolimus in Pediatric Patients With Advanced Solid Tumors
Actual Study Start Date : January 30, 2012
Actual Primary Completion Date : August 20, 2013
Estimated Study Completion Date : July 9, 2018

Arm Intervention/treatment
Experimental: Ridaforolimus Drug: ridaforolimus
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



Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities (DLTs) [ Time Frame: First 28-day cycle ]
  2. Ridaforolimus geometric mean area under the concentration curve from hour 0 to hour 24 (AUC0-24). [ Time Frame: Cycle 1, Day 5 ]


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01431534     History of Changes
Other Study ID Numbers: 8669-056
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs