drugset

drugset / Trial / NCT03072043

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

NCT03072043 ↗

Phase 1/2 Completed 55 enrolled H. Lee Moffitt Cancer Center and Research Institute Aprea Therapeutics · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

The main purpose of this study is to determine the safe and recommended dose of APR-246 in combination with azacitidine as well as to see if this combination of therapy improves overall survival.

Timeline

Start: 2017-05-18
Primary completion: 2019-11-15
Completion: 2021-12-08

Publications

Sallman DA, DeZern AE, Garcia-Manero G, Steensma DP, Roboz GJ, Sekeres MA, Cluzeau T, Sweet KL, McLemore A, McGraw KL, Puskas J, Zhang L, Yao J, Mo Q, Nardelli L, Al Ali NH, Padron E, Korbel G, Attar EC, Kantarjian HM, Lancet JE, Fenaux P, List AF, Komrokji RS. Eprenetapopt (APR-246) and Azacitidine in TP53-Mutant Myelodysplastic Syndromes. J Clin Oncol. 2021 May 10;39(14):1584-1594. doi: 10.1200/JCO.20.02341. Epub 2021 Jan 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	eprenetapopt	Small molecule	50 mg/kg	Intravenous
Background	Azacitidine	Other / unclassified	75 mg/m2	Subcutaneous

Indications