drugset

drugset / Trial / NCT00590187

Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients

NCT00590187 ↗

Phase 2 Completed 105 enrolled Cyclacel Pharmaceuticals, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective is to treat elderly AML and MDS patients with sapacitabine.

Timeline

Start: 2007-12
Primary completion: 2018-12-01
Completion: 2018-12-01

Publications

Results Kantarjian H, Faderl S, Garcia-Manero G, Luger S, Venugopal P, Maness L, Wetzler M, Coutre S, Stock W, Claxton D, Goldberg SL, Arellano M, Strickland SA, Seiter K, Schiller G, Jabbour E, Chiao J, Plunkett W. Oral sapacitabine for the treatment of acute myeloid leukaemia in elderly patients: a randomised phase 2 study. Lancet Oncol. 2012 Nov;13(11):1096-104. doi: 10.1016/S1470-2045(12)70436-9. Epub 2012 Oct 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sapacitabine	Small molecule	100 mg	Oral
Subject	sapacitabine	Small molecule	200 mg	Oral
Subject	sapacitabine	Small molecule	300 mg	Oral
Subject	sapacitabine	Small molecule	400 mg	Oral

Indications