A Safety and Efficacy Study of Eltrombopag in Subjects With AML

Phase 2 Completed 148 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this randomized, blinded, placebo-controlled study was to provide clinical safety and exploratory efficacy data on the use of Eltrombopag in adult subjects with Acute Myeloid Leukemia (AML) receiving standard induction chemotherapy with daunorubicin plus cytarabine. A minimum of 120 evaluable subjects newly diagnosed with AML was stratified by antecedent malignant hematologic disorder and age.

Timeline

Start: 2013-09-05
Primary completion: 2015-03-13
Completion: 2017-01-25

Publications

Frey N, Jang JH, Szer J, Illes A, Kim HJ, Ram R, Chong BH, Rowe JM, Borisenkova E, Liesveld J, Winer ES, Cherfi A, Aslanis V, Ghaznawi F, Strickland S. Eltrombopag treatment during induction chemotherapy for acute myeloid leukaemia: a randomised, double-blind, phase 2 study. Lancet Haematol. 2019 Mar;6(3):e122-e131. doi: 10.1016/S2352-3026(18)30231-X. Epub 2019 Jan 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eltrombopag	Small molecule	150 mg	Oral
Subject	Eltrombopag	Small molecule	300 mg	Oral
Background	Cytarabine	Small molecule	100 mg/m2	Intravenous
Background	Daunorubicin	Small molecule	60 mg/m2	Intravenous
Background	Daunorubicin	Small molecule	90 mg/m2	Intravenous

A Safety and Efficacy Study of Eltrombopag in Subjects With AML

Summary

Timeline

Publications

Drugs

Indications