Trial intelligence / Profile preview

ATG-016 (Eltanexor) in MDS Post-HMA Failure

NCT04691141Phase 2

Key facts

Status: Terminated
Start: Feb 2021
Primary completion: Sep 2023
Countries: 1
Sponsor: Antengene
Modality: Small Molecules

Drugs: eltanexor
Conditions: myelodysplastic syndrome (MDS)

Overview

Phase 2, open-label, single-arm trial of eltanexor in myelodysplastic syndrome (MDS), sponsored by Antengene. Primary endpoints: Maximum Tolerated Dose at 16 months, Recommended Phase 2 Dose at 16 months and 2 more. Started Feb 2021; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

ATG-016 Monotherapy
Participants receive ATG-016 orally.

Who it enrols

Patients aged 18 or older with IPSS-R Intermediate Risk and above Myelodysplastic Syndrome (MDS) who have failed HMA-based therapy.

Endpoints

Primary

Maximum Tolerated Dose16 months
Recommended Phase 2 Dose16 months
Adverse Events25 months
Overall Response Rate25 months

Secondary

Disease Control Rate12 months
Duration of Response12 months
Progression-Free Survival12 months
Overall Survival12 months

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