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A Phase Ib/II Multicenter Open-label Study of Bemcentinib (BGB324) in Patients With AML or MDS

NCT02488408 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2024-12-19

Study results available
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Summary

A Phase Ib/II multicentre open label study of bemcentinib (BGB324) as a single agent in participants with Acute Myeloid Leukemia (AML) or Myelodysplastic syndrome (MDS) or in a combination with cytarabine or decitabine in AML participants.

Bemcentinib is a potent selective small molecule inhibitor of AXL a surface membrane protein kinase receptor which is overexpressed in up to half of AML cases.

Conditions

Interventions

DRUG

Bemcentinib

DRUG

Cytarabine

DRUG

Decitabine

Sponsors & Collaborators

  • BerGenBio ASA

    lead INDUSTRY

Principal Investigators

  • Sonja Loges, MD · Universitätsmedizin Mannheim, Universitätsklinikum Mannheim GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-22
Primary Completion
2022-06-08
Completion
2022-06-08
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Italy
  • Norway

Study Locations

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Entities

Drugs
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 NCT02488408 on ClinicalTrials.gov