Efficacy & Safety Study of KPT-330 in Erythropoietin-Refractory Lower-Risk Myelodysplastic Syndrome Patients

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT02431351
Phase
PHASE2
Status
Withdrawn

Conditions

  • Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    60 mg on Day 1 of each week for a 4 week cycle, given for ≥6 cycles.

Study Details

This is an open-label study designed to evaluate the safety and efficacy of the selective inhibitor of nuclear export (SINE) compound, Selinexor given orally to patients with transfusion-dependent, EPO-refractory lower-risk MDS (Low risk and Intermediate-1 as defined by IPSS).

Key Dates

Start date
Nov 30, 2015
Status verified
Jan 2023
Primary completion
Dec 31, 2017
Completion
May 31, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor
    60 mg once weekly

Primary Outcome Measure

Hematologic improvement (based on the 2006 International Working Group (IWG) response criteria) [ Time Frame: 6 months ]

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