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HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.

NCT04496999 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-10-06

No results posted yet for this study

Summary

This is a non-randomized prospective open-label single-arm clinical phase I trial investigating dose finding, feasibility and safety of the combined treatment of HDM201 and midostaurin in patients with relapsed/refractory acute myeloid leukemia (AML) with FLT3mut applying an accelerated titration design.

Conditions

  • AML, Adult

Interventions

DRUG

HDM201

Dose level 0: HDM201 40 mg QD d1,2 (midday)/ Dose level 1: HDM201 40 mg QD d1,2,3 (midday) = Starting dose/ Dose level 2: HDM201 40 mg QD d1,2,3,4,5 (midday)/ Dose level 3: HDM201 60 mg QD d1,2,3,4,5 (midday)/ Dose level 4: HDM201 80 mg QD d1,2,3,4,5 (midday)

DRUG

Midostaurin

Midostaurin 50mg bid d1-28 (morning, evening)

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Thomas Pabst, Prof · Department of Medical Oncology, University Hospital Bern Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2022-09-09
Completion
2022-09-09

Countries

  • Switzerland

Study Locations

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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 NCT04496999 on ClinicalTrials.gov