Study of 72-Hour Infusion of ON 01910.Na in Patients With MDS or AML
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the efficacy and safety of ON 01910.Na
Concentrate when it is administered as an intravenous continuous infusion (IVCI) over 72
hours once every 2 weeks in a broad population of MDS patients. Rationale for this study is
based on the activity observed in another study with ON 01910.Na in patients with refractory
anemia with excess blasts (RAEB) 1 and 2 MDS. This study will examine ON 01910.Na in a
broader population of MDS and AML patients. This phase I/II study will establish the Maximum
Tolerated Dose (MTD) starting with a dose of 800 mg/m2 per day administered over 24 hours for
2 consecutive days as a continuous intravenous infusion, once a week for 3 weeks of a 4-week
cycle and examine the efficacy and safety profile at the MTD.