A Multi-Center Phase I Study of Intravenous Deforolimus (AP23573, MK-8669) Administered QDX5 Every Other Week in Pediatric Patients With Advanced Solid Tumors (8669-028)(COMPLETED)

• Status: Completed
• Trial end date: 2010-06-01

Summary

Ridaforolimus (Deforolimus, AP23573, MK-8669) is an mTor inhibitor shown to have promising activity in adults with a variety of solid malignancies, particularly the sarcomas. To date, no studies to evaluate appropriate dosing or to obtain pharmacokinetic data in pediatric patients have been conducted. Sarcomas are the second most common solid malignancies in children and young adults, and for those patients with recurrent or refractory disease, new therapies are needed. This initial evaluation of ridaforolimus will help define appropriate dosing and toxicity evaluations, as well as establish the first pharmacokinetic and biologic correlative data in pediatric patients treated with ridaforolimus.

• Phase: Phase 1

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborators: H. Lee Moffitt Cancer Center and Research Institute; Johns Hopkins All Children's Hospital; Memorial Sloan Kettering Cancer Center; Pediatric Cancer Foundation; University of Colorado, Denver
• Treatments: Sirolimus