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A Phase I Study of Ridaforolimus in Pediatric Patients With Advanced Solid Tumors

Phase 1
6 Years
17 Years
Open (Enrolling)
Solid Tumors

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Trial Information

A Phase I Study of Ridaforolimus in Pediatric Patients With Advanced Solid Tumors

Inclusion 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with dose limiting toxicities (DLTs)

Outcome Time Frame:

First 28-day cycle

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

August 2013

Related Keywords:

  • Solid Tumors
  • Neoplasms