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)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00960063
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Temozolomide — DRUG
  • Vincristine — DRUG
  • Ifosfamide — DRUG
  • Irinotecan — DRUG
  • Robatumumab — BIOLOGICAL
  • Doxorubicin — DRUG
  • Cyclophosphamide — DRUG
  • Etoposide — DRUG

Study Details

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.

Key Dates

Start date
Nov 11, 2009
Status verified
Jul 2018
Primary completion
Dec 22, 2010
Completion
Dec 22, 2010

Study Design

Enrollment
4 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Temozolomide+Irinotecan+Robatumumab
    Participants receive temozolomide 100 mg/m\^2/day intravenously (IV) on Days 1-5 PLUS irinotecan 10 mg/m\^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
  • Experimental: Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab
    Participants receive vincristine 2 mg/m\^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m\^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m\^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
  • Experimental: Ifosfamide+Etoposide+Robatumumab
    Participants receive ifosfamide 1800 mg/m\^2 per day IV PLUS etoposide 100 mg/m\^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities [ Time Frame: Up to ~30 days after last dose of study drug (Up to ~10.3 months) ]

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