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 P05883
- Each subject must be <= 21 years of age (older subjects may be allowed on study on a
case-by-case basis). A subject may be of either sex, and of any race/ethnicity.
- Each subject must have histologic confirmation of the advanced solid tumor, except
for brainstem tumors.
- Each subject must have Karnofsky performance score of >= 50 (if subject is > 16 years
of age) or a Lansky score of > 50 (if subject is <= 16 years of age).
- Each subject must have adequate organ function during Screening.
- Each subject must be able to adhere to dose and visit schedules.
- A subject must not have a history of another malignancy.
- A subject must not have uncontrolled diabetes mellitus.
- A subject must not have persistent, unresolved common terminology criteria for
adverse events (CTCAE) Grade >=2 drug-related toxicity associated with previous
- A subject must not have known hypersensitivity to other antibodies, or any
accompanying excipients associated with these medications.
- A female subject must not be breast-feeding, pregnant, intending to become pregnant,
or have a positive pregnancy test at Screening.
- A subject must not be known to have human immunodeficiency virus (HIV) infection or
known HIV-related malignancy.
- A subject must not be known to have active Hepatitis B, or Hepatitis C.
- A subject must not have any serious or uncontrolled infection.