Stopped: Data for the primary objectives is complete and the MTD identified in Stratum II.
This phase I trial studies the side effects and best dose of palbociclib isethionate in treating younger patients with central nervous system tumors that have grown, come back, or not responded to treatment. Palbociclib isethionate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Age range
4 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Maximum Tolerated Dose (MTD) of Palbociclib in Stratum I
Timeframe: 4 weeks
Maximum Tolerated Dose (MTD) of Palbociclib in Stratum II
Timeframe: 4 weeks
Number of Patients Who Experienced Dose Limiting Toxicities (DLTs)
Timeframe: 4 weeks
Single Dose Apparent Volume of Central Compartment (Vc/F)
Timeframe: Up to day 3
Single Dose Elimination Rate Constant (Ke)
Timeframe: Up to day 3
Single Dose Half-life (t1/2)
Timeframe: Up to day 3
Single Dose Apparent Oral Clearance (CL/F)
Timeframe: Up to day 3
Single Dose Area Under the Plasma Concentration Time Curve (AUC)
Timeframe: Up to day 3
Steady State Apparent Volume of Central Compartment (Vc/F)
Timeframe: Up to day 22
Steady State Elimination Rate Constant (Ke)
Timeframe: Up to day 22
Steady State Half-life (t1/2)
Timeframe: Up to day 22
Steady State Apparent Oral Clearance (CL/F)
Timeframe: Up to day 22
Steady State Area Under the Plasma Concentration Time Curve (AUC)
Timeframe: Up to day 22