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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


Phase 1
N/A
21 Years
Not Enrolling
Both
Neoplasms, Solid Tumors, Bone Cancer, Kidney Tumor, Neuroblastoma

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Trial Information

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


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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
treatment.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

All Dose Limiting Toxicities tabulated by treatment arm and dose level

Outcome Time Frame:

From beginning of treatment to approximately 30 days after the final dose of SCH 717454 or the standard treatment assigned (whichever is last). Data will be collected at all visits.

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

P05883

NCT ID:

NCT00960063

Start Date:

November 2009

Completion Date:

December 2010

Related Keywords:

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

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