The Pivotal MDS Trial INSPIRE
is Now Recruiting Patients
INternational Study of Phase III Intravenous RigosErtib
STUDY DESCRIPTION
A Phase III, international, randomized, controlled study of Rigosertib + best supportive care
versus physician's choice of treatment + best supportive care in patients with myelodysplastic
syndrome (MDS) after failure of a hypomethylating agent (HMA).
2:1
Eligibility:
• MDS subtypes RAEB-1,
RAEB-2 or RAEB-t
• Progression or failure
to respond to HMA
• HMA treatment duration
≤ 9 months
• <80 years of age
Rigosertib + best
supportive care
N = 150
PRIMARY
ENDPOINT:
Overall
Survival
Physician’s Choice
of Treatment + best
supportive care
N = 75
PRIMARY ENDPOINTS
Overall survival in the intention-to-treat population and in patients with very high risk per the Revised
International Prognosis Scoring System (Greenberg et al, Blood 2012).
LOCATIONS
North America, Europe, Japan, Australia, Israel
For additional information on this study, please call the INSPIRE help line at
1-267-759-3676 or visit www.clinicaltrials.gov, identifier: NCT02562443.
Rigosertib is an investigational agent and is not approved by the FDA or other
regulatory agencies worldwide as a treatment for any indication.
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