Status:
TERMINATED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Neoplasms
Solid Tumors
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief 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, ...
Eligibility Criteria
Inclusion
- Must be \<= 21 years of age (older participants may be allowed on study on a case-by-case basis); may be of either sex, and of any race/ethnicity.
- Must have histologic confirmation of the advanced solid tumor, except for brainstem tumors.
- Must have Karnofsky performance score of \>=50 (if participant is \>16 years of age) or a Lansky score of \>50 (if participant is \<=16 years of age).
- Must have adequate organ function during Screening.
- Must be able to adhere to dose and visit schedules.
Exclusion
- Must not have a history of another malignancy.
- Must not have uncontrolled diabetes mellitus.
- Must not have persistent, unresolved common terminology criteria for adverse events (CTCAE) Grade \>=2 drug-related toxicity associated with previous treatment.
- Must not have known hypersensitivity to other antibodies, or any accompanying excipients associated with these medications.
- If female, must not be breast-feeding, pregnant, intending to become pregnant, or have a positive pregnancy test at Screening.
- Must not be known to have human immunodeficiency virus (HIV) infection or known HIV-related malignancy.
- Must not be known to have active Hepatitis B, or Hepatitis C.
- Must not have any serious or uncontrolled infection.
Key Trial Info
Start Date :
November 11 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00960063
Start Date
November 11 2009
End Date
December 22 2010
Last Update
August 27 2018
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