Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
128actual
Sites
101
Countries
Brazil, Canada, Czechia +11
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-05-24 | actual | When the study began enrolling |
| Primary completion | 2024-08-26 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-18 | estimated | The whole study's end, after follow-up |
| First posted | 2018-10-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-01-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Ewing Sarcoma
- Solid Tumors
- Rhabdoid Tumor
- Rhabdomyosarcoma
- Neuroblastoma
- Medulloblastoma
- Diffuse Intrinsic Pontine Glioma
Interventions
- Drug: Palbociclib — also filed as Ibrance
- Drug: Temozolomide — also filed as Temodar
- Drug: Irinotecan — also filed as Campto
- Drug: Topotecan — also filed as Hycamtin
- Drug: Cyclophosphamide — also filed as Cytoxan
Primary outcomes
what the primary-completion date above is the date OFPhase 2 open-label, randomized: Event-free survival (EFS) based on Investigator assessment.
measured Baseline to Month 24.
Phase 1: First Cycle Dose-Limiting Toxicities (DLT)
measured First cycle (cycle length is approximately 21 days)
Phase 1: Dose Expansion Parts: Frequency of adverse events
measured At least 28 days after last dose
Phase 1: Dose Expansion Parts: Percentage of Participants With Complete Response or Partial Response
measured Through the end of treatment (up to at least 28 days after last dose)
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