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HDM201 Added to CT in R/R or Newly Diagnosed AML

NCT03760445 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2020-01-09

No results posted yet for this study

Summary

This is a multi-center open-label Phase I/II study investigating orally administered HDM201 in combination with chemotherapy in two populations: subjects with first line AML or subjects with relapsed/refractory AML. This study is conducted in three parts: dose escalation, dose expansion and DDI study.

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DRUG

HDM201

2.5 mg and 10mg capsules, given orally

DRUG

cytarabine

20mg or 1000 mg or other strengths as locally available given intravenously

DRUG

anthracycline

20mg or other strength as locally available given intravenously

DRUG

midostaurin

25mg capsules given orally

DRUG

liposomal cytarabine/daunorubicin

100mg/44mg or other strength as locally available given intravenously

DRUG

posaconazole

100mg delayed release tablet or other strength as locally available given orally

DRUG

midazolam

2mg/mL oral solution or in other strength as locally available

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2021-07-22
Completion
2023-06-13
FDA Drug
Yes

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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 NCT03760445 on ClinicalTrials.gov