NCT00960063

A Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Pediatric Participants With Advanced Solid Tumors (P05883, MK-7454-006)

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Neoplasms
• Solid Tumors
• Bone Cancer
• Kidney Tumor
• Neuroblastoma

Interventions

Type	Name	Description
DRUG	Temozolomide
DRUG	Vincristine
DRUG	Ifosfamide
DRUG	Irinotecan
BIOLOGICAL	Robatumumab
DRUG	Doxorubicin
DRUG	Cyclophosphamide
DRUG	Etoposide

Timeline

• Start date: 2009-11-11
• Primary completion: 2010-12-22
• Completion: 2010-12-22
• First posted: 2009-08-17
• Last updated: 2018-08-27
• Results posted: 2016-02-10