drugset / Trial / NCT05627232
Tazemetostat and Palbociclib With CPX-351for R/R AML
Phase 1
Recruiting
24 enrolled
Thomas Jefferson University
Pennsylvania Department of Health · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a two-part phase Ib dose escalation study to evaluate the safety and preliminary efficacy of the combination of tazemetostat and CPX-351 (Part 1) and of pre-treatment with palbociclib followed by CPX-351 (Part 2) for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). Part 1 of the study will seek to establish the safety, tolerability, biological activity and recommended dose for further evaluation (RDFE) of tazemetostat in combination with standard-dose CPX-351. Part 2 of the study will seek to establish the safety, tolerability, biological activity RDFE of pre-treatment palbociclib prior CPX-351.
Timeline
- Start
- 2023-08-28
- Primary completion
- 2028-01
- Completion
- 2029-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CPX-351 | Other / unclassified | — | Intravenous |
| Subject | Palbociclib | Small molecule | — | Oral |
| Subject | Tazemetostat | Small molecule | — | Oral |