drugset / Trial / NCT03844997

Phase I/II Trial of CPX-351 + Palbociclib in Patients With Acute Myeloid Leukemia

NCT03844997

Phase 1/2 Completed 35 enrolled Sudipto Mukherjee, MD, PhD, MPH
NaSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of Palbociclib in combination with investigational (experimental) drug, CPX-351 and evaluate the efficacy of Palbociclib in combination with chemotherapy as measured by overall response rate (ORR), i.e. complete response (CR) and CR with incomplete blood count recovery (CRi) by 2003 IWG criteria.

Timeline

Start
2019-06-06
Primary completion
2024-01-24
Completion
2024-01-24

Drugs

EvaluationDrugModalityDoseRoute
Subject CPX-351 Other / unclassified 100 unknown Intravenous
Subject Palbociclib Small molecule 100 mg Oral
Subject Palbociclib Small molecule 125 mg Oral