Solid Tumors Clinical Trial
Official title:
A Phase I Study of Ridaforolimus in Pediatric Patients With Advanced Solid Tumors
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-limiting toxicities (DLTs) while on different doses of ridaforolimus, and
to characterize the pharmacokinetics of ridaforolimus in these participants. The primary
hypotheses of this study are that 1) the DLTs observed will be dose-dependent and allow for
definition of a maximum tolerated dose (MTD) and 2) at a safe and well tolerated dose,
ridaforolimus geometric mean (GM) Day-5 blood area under the concentration-time curve at 24
hours (AUC0-24) exceeds 75% (or 1304-ng*hr/mL) of the estimated GM Day-5, 40-mg AUC0-24 in
adults.
Study-related visits concluded in August 2013. Participants who did not have disease
progression, adequately tolerated therapy, and continued to meet eligibility criteria for 6
months after the enrollment period had been completed could continue treatment in an
extension phase until they met discontinuation criteria or voluntarily withdrew.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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