Solid Tumor Treatment with Palbociclib – Phase I

ADVL1921: Study to Evaluate the Safety and Pharmacokinetics of Palbociclib (IBRANCE®) in Combination with Irinotecan and Temozolomide in Pediatric Patients with Recurrent or Refractory Solid Tumors

Protocol Description

Through this multi-center Children’s Oncology Group study, researchers are evaluating palbociclib, known by the trade name IBRANCE®, in combination with chemotherapy with temozolomide (TMZ) and irinotecan (IRN) in children, adolescents, and young adults with recurrent or refractory solid tumors. Researchers will be evaluating how the body processes the drug, side effects, therapeutic effects, and drug tolerance to determine optimal dosage levels.

Study Level: Phase I

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients who have a recurrent and/or refractory malignant solid tumor for which there is no standard of care treatment.
Males and Females: 2 to 20 years of age


Participants will take the study drug in capsule or liquid form once daily for days 1-14 of each 21-day cycle. TMZ and IRN will be given daily on days 1 to 5 and require visits to the study doctor for intravenous infusion of IRN. Various other tests and imaging will be done at intervals specified by the protocol. Participants may remain in the study for up to 2 years providing their tumor has not advanced, that they are not having severe side effects.
Visits: On days 1-5 of each 21-day cycle, with additional evaluations during cycle 1 of therapy
Duration: Up to 2 years

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1921)

Primary Investigator

Andrew Bukowinski, MD

Contact Information

For more information about the study or enrollment, please contact:
Sharon Dibridge, Clinical Research Coordinator