Neoplasms Clinical Trial
Official title:
A Phase 1/1B Dose-Escalation Study to Determine the Safety and Tolerability of SCH 717454 Administered in Combination With Chemotherapy in Pediatric Subjects With Advanced Solid Tumors (Protocol No. 05883)
This is a Phase 1/1B, non-randomized, open-label, dose-escalation study of robatumumab (SCH
717454, MK-7454) administered in combination with chemotherapy in pediatric participants with
solid tumors, to be conducted in conformance with Good Clinical Practices. This study will
evaluate the safety, tolerability and dose-finding of robatumumab when administered in
combination with temozolomide and irinotecan (Arm A); or cyclophosphamide, doxorubicin, and
vincristine (Arm B), or ifosfamide and etoposide (Arm C).
The primary study hypothesis is that robatumumab can be safely administered in combination
with chemotherapy regimens in pediatric participants with solid tumors.
n/a
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