Safety and Pharmacology Study of Sapacitabine to Treat Advanced Leukemias or Myelodysplastic Syndromes

Phase 1 Completed 47 enrolled Cyclacel Pharmaceuticals, Inc.

Non-randomizedSequentialOpen-labelTreatment

Summary

The goal of this safety/pharmacology study is to determine MTD of sapacitabine when administered in patients with advanced leukemias or myelodysplastic syndromes.

Timeline

Start: 2006-01
Primary completion: 2008-11
Completion: 2009-06

Publications

Results Kantarjian H, Garcia-Manero G, O'Brien S, Faderl S, Ravandi F, Westwood R, Green SR, Chiao JH, Boone PA, Cortes J, Plunkett W. Phase I clinical and pharmacokinetic study of oral sapacitabine in patients with acute leukemia and myelodysplastic syndrome. J Clin Oncol. 2010 Jan 10;28(2):285-91. doi: 10.1200/JCO.2009.25.0209. Epub 2009 Nov 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sapacitabine	Small molecule	75 mg	Oral
Subject	sapacitabine	Small molecule	100 mg	Oral
Subject	sapacitabine	Small molecule	125 mg	Oral
Subject	sapacitabine	Small molecule	175 mg	Oral
Subject	sapacitabine	Small molecule	225 mg	Oral
Subject	sapacitabine	Small molecule	275 mg	Oral
Subject	sapacitabine	Small molecule	325 mg	Oral
Subject	sapacitabine	Small molecule	375 mg	Oral
Subject	sapacitabine	Small molecule	425 mg	Oral
Subject	sapacitabine	Small molecule	475 mg	Oral

Safety and Pharmacology Study of Sapacitabine to Treat Advanced Leukemias or Myelodysplastic Syndromes

Summary

Timeline

Publications

Drugs

Indications