NCT00531232

A Dose Confirmation Study of Oral Clofarabine for Adult Patients Previously Treated for Myelodysplastic Syndromes (MDS)

A Phase IIa Open-label, Dose Confirmation Study of Oral Clofarabine in Adult Patients Previously Treated for Myelodysplastic Syndromes (MDS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndromes
• Secondary Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	Clofarabine	Pharmaceutical form: Tablet, Route of administration: Oral

Timeline

• Start date: 2007-05-07
• Primary completion: 2011-05-12
• Completion: 2011-05-12
• First posted: 2007-09-18
• Last updated: 2022-03-24
• Results posted: 2021-11-02

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study