NCT03072043View on ClinicalTrials.gov

Phase 1b/2 Safety and Efficacy of APR-246 w/Azacitidine for tx of TP53 Mutant Myeloid Neoplasms

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

May 18, 2017

Primary Completion Date

November 15, 2019

Study Completion Date

December 8, 2021

Conditions
Myelodysplastic SyndromeAcute Myeloid LeukemiaMyeloproliferative NeoplasmChronic Myelomonocytic Leukemia
Interventions
DRUG

APR-246

Phase 1b: Dose escalation of APR-246 via intravenous (IV) infusion, with starting dose of 50 mg/kg lean body weight (LBW). Phase 2: APR-246 at maximum tolerated dose (MTD).

DRUG

Azacitidine

Azacitidine is administered subcutaneously (SC) or via IV at 75 mg/m\^2.

Trial Locations (6)

10065

Weill Medical College of Cornell University, New York

21231

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

44195

Cleveland Clinic Taussig Cancer Center, Cleveland

77030

University of Texas M.D. Anderson Cancer Center, Houston

02215

Dana-Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

Aprea Therapeutics
All Listed Sponsors
collaborator

Aprea Therapeutics

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER