At a glance
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A Phase IIa Open-label, Dose Confirmation Study of Oral Clofarabine in Adult Patients Previously Treated for Myelodysplastic Syndromes (MDS)
In Brief
A Phase 2 clinical trial evaluating Clofarabine for Myelodysplastic Syndromes and Secondary Acute Myeloid Leukemia (AML). Completed, enrolled 38 participants across 6 sites.
Detailed Summary
There was no well accepted standard of care for participants who failed or were intolerant to any of the currently approved therapies for myelodysplastic syndromes (MDS). In this study, participants were initially assigned to receive 55 or 35 milligrams (mg) of oral clofarabine daily for 5 days. After safety review of the first participants enrolled, the dose was reduced to 25 milligrams per day (mg/day) for up to 8 cycles as long as the participants continued to benefit and in the absence of progressive disease.
Study Details
Timeline
Interventions
Pharmaceutical form: Tablet, Route of administration: Oral