A Phase I, Dose-escalation Study of AS703569 Given Orally to Subjects With Haematological Malignancies

Phase 1 Terminated 124 enrolled EMD Serono

Non-randomizedParallel-groupOpen-labelTreatment

Summary

EMD Serono decided to terminate enrollment based on a review of the available clinical data and low probability of completing the trial based on the observed recruitment rate. Subjects already enrolled in the study continued participation in the study, consistent with the protocol, to study completion.

Timeline

Start: 2006-12
Primary completion: 2010-03
Completion: 2011-08

Outcome

Outcome not reported

Stopped: “Please see Purpose Statement below”

Publications

Graux C, Sonet A, Maertens J, Duyster J, Greiner J, Chalandon Y, Martinelli G, Hess D, Heim D, Giles FJ, Kelly KR, Gianella-Borradori A, Longerey B, Asatiani E, Rejeb N, Ottmann OG. A phase I dose-escalation study of MSC1992371A, an oral inhibitor of aurora and other kinases, in advanced hematologic malignancies. Leuk Res. 2013 Sep;37(9):1100-6. doi: 10.1016/j.leukres.2013.04.025. Epub 2013 Jun 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CENISERTIB	Small molecule	28 mg/m2	Oral
Subject	CENISERTIB	Small molecule	37 mg/m2	Oral