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Withdrawn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

First listed
May 1, 2015
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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