Study of Ibrutinib in Subjects With Acute Myeloid Leukemia

Phase 2 Terminated 36 enrolled Pharmacyclics LLC.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of ibrutinib alone or in combination with either cytarabine or azacitidine in the treatment of subjects with Acute Myeloid Leukemia (AML) who have failed standard treatment, or subjects without prior therapy who refuse standard chemotherapy.

Timeline

Start: 2015-02
Primary completion: 2017-04
Completion: 2017-04

Outcome

Outcome not reported

Stopped: “Study data do not support development in AML.”

Publications

Wilken R, Li CS, Sharon VR, Kim K, Patel FB, Patel F, Maverakis E. Topical clobetasol for the treatment of toxic epidermal necrolysis: study protocol for a randomized controlled trial. Trials. 2015 Aug 22;16:374. doi: 10.1186/s13063-015-0879-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacitidine	Other / unclassified	75 mg/m2	Intravenous
Subject	Azacitidine	Other / unclassified	100 mg/m2	Intravenous
Subject	Ibrutinib	Small molecule	560 mg	—
Subject	LD-AraC	Unknown	20 mg	Subcutaneous