NCT03760445

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

A Phase I/II Multi-center Study of HDM201 Added to Chemotherapy in Adult Subjects With Relapsed/Refractory (R/R) or Newly Diagnosed Acute Myeloid Leukemia (AML)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1 / 2 study. No patients were screened / enrolled. There are no data collected. There will be no CSR.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-11-15
• Primary completion: 2021-07-22
• Completion: 2023-06-13
• First posted: 2018-11-30
• Last updated: 2020-01-09

Regulatory

• FDA-regulated drug study