Phase 1/2 Study to Evaluate the Safety and Pharmacokinetics of Palbociclib (Ibrance®) in Combination with Irinotecan and Temozolomide and in Combination with Topotecan and Cyclophosphamide in Pediatric Patients with Recurrent or Refractory Solid

Contact:

NCT Number:

Protocol:

AAAS2961

Study Status:

Active/Enrolling

Population:

Pediatrics/Adult

Phase:

II

The purpose of this study is to find the best dose of Palbociclib that can be given safely with chemotherapy in children with solid tumor which has come back or has not responded to the standard therapy. Palbociclib works by targeting proteins that are necessary for cell growth. Palbociclib will be given by mouth on Days 1-14 of 21-day cycle. It will be given in combination with chemptherapy drugs Irinotecan and Temozolomide.

Are you Eligible? (Inclusion Criteria)

  • Patients must have recurrent or refractory solid tumors
  • Patients must be ≥2 and <21 years of age
  • Patients must also meet all eligibility criteria as outlined in the study
  • protocol

Specialty Area(s)

Childhood and Adolescent Cancers (Pediatric), Pediatric: Solid Tumors

Principal Investigator

Profile Headshot
  • Section Head of Oncology, Division of Hematology, Oncology, and Stem Cell Transplant

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032