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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

June 6, 2019

Primary Completion Date

January 24, 2024

Study Completion Date

January 24, 2024

Conditions
Acute Myeloid LeukemiaAML
Interventions
DRUG

Palcociclib

"Palbociclib is an investigational (experimental) drug that works to induce early G1 arrest by inhibiting CDK4/6, which are two types of CDKs that are overexpressed in AML cell cancer lines. Palbociclib is experimental because it is not approved by the Food and Drug Administration (FDA).~Palbociclib will be supplied as capsules or tablets containing 125 mg equivalents of Palbociclib free base"

DRUG

CPX-351

CPX-351 (daunorubicin and cytarabine) liposome for injection is a combination of daunorubicin and cytarabine in a 1:5 molar ratio encapsulated in liposomes for intravenous administration. CPX-351 is an investigational (experimental) drug that works as formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. CPX-351 is experimental because it is not approved by the Food and Drug Administration (FDA).

Trial Locations (1)

44195

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
lead

Sudipto Mukherjee, MD, PhD, MPH

OTHER

NCT03844997 - Phase I/II Trial of CPX-351 + Palbociclib in Patients With Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter