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Evaluating the Efficacy and Safety of Bemcentinib in Patients With Myelodysplastic Syndromes

NCT03824080 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-12-21

No results posted yet for this study

Summary

This is an open-label, single-arm multicenter, phase II study. The primary objective is to assess the efficacy of bemcentinib (BGB324) a highly selective inhibitor of the AXL receptor tyrosine kinase for the treatment of AML and MDS patients failing or being refractory to first line hypomethylating agent (HMA) treatment. Furthermore, safety, disease progression, treatment failure will be assessed. A total of 43 patients will be included in the trial.

Conditions

Interventions

DRUG

Bemcentinib

Bemcentinib will be self-administered orally (fasted) at a dose mentioned above for a total of at least 4 cycles daily. Responding patients (defined as at least stable disease) are eligible for up to 5 additional cycles according to the maintenance daily dosing of 2 x 1 capsules of 100 mg for each 28 days cycle (up to 9 cycles in total).

Sponsors & Collaborators

  • Groupe Francophone des Myelodysplasies

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • BerGenBio ASA

    collaborator INDUSTRY

  • GWT-TUD GmbH

    lead OTHER

Principal Investigators

  • Uwe Platzbecker, Prof. · Universitätsklinikum Leipzig

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2020-07-13
Completion
2021-06-08

Countries

  • France
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03824080 on ClinicalTrials.gov