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Phase 1/2 Study to Evaluate Palbociclib (IBRANCE?) in Combination with Irinotecan and Temozolomide or in Combination with Topotecan and Cyclophosphamide in Pediatric Patients with Recurrent or Refractory Solid Tumors.

1. To estimate the MTD for the combination of Palbociclib, TMZ, and IRN in children, adolescents, and young adults with recurrent or refractory solid tumors.

2. To characterize the safety profile of the palbociclib combined with TMZ and IRN.

3. To describe the PK of palbociclib, TMZ, and IRN in children, adolescents, and young adults with recurrent or refractory solid tumors when given in combination.

4. To evaluate the antitumor activity of palbociclib combined with TMZ and IRN


5. To evaluate the safety, and confirm the RP2D for the combination of palbociclib, TMZ, and IRN at the MTD in children, adolescents and young adults with recurrent or refractory solid tumors that are known to be sensitive to a CDK4/6 inhibitor

6. To evaluate the antitumor activity of palbociclib combined with TMZ and IRN.

7. To characterize candidate biomarkers of sensitivity or resistance in pre treatment tumor tissue that may aid in the identification of patient subpopulations most likely to benefit from treatment.

8. To explore pharmacodynamics (PD) modulation of thymidine kinase (TK)-1 activity in blood following palbociclib exposure

9. To evaluate preliminary information on the palatability of the oral solution formulation of palbociclib

Protocol Number: 111901
Phase: Phase I
Applicable Disease Sites: Any Site
Drugs Involved: IRINOTECAN
TEMOZOLOMIDE
Palbociclib
Principal Investigator: Scott Moerdler M.D.
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

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