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Selinexor in Refractory Myelodysplastic Syndromes
NCT02228525Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2014
- Primary completion
- Apr 2021
- Countries
- 1
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Modality
- Small Molecules
- Drugs
- selinexor
- Conditions
- myelodysplastic syndrome (MDS)
01
Overview
Phase 2, open-label, single-arm trial of selinexor in myelodysplastic syndrome (MDS), sponsored by Memorial Sloan Kettering Cancer Center. Primary endpoint: Best Overall Response Rate at 2 years. Started Aug 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
selinexor (KPT-330)
Patients receive oral selinexor at a starting dose of 60 mg twice weekly for 2 weeks, followed by 1 week of no therapy.
03
Who it enrols
Adult patients with Myelodysplastic Syndromes refractory to hypomethylating agents (decitabine or 5-azacytidine), with ECOG 0-2, adequate organ function, and no active infections or other malignancies.
04
Endpoints
Primary
Best Overall Response Rate
Secondary
Response Duration
Overall Survival
Participants Evaluated for Adverse Events
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