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drugset / Trial / NCT03760445

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

NCT03760445 ↗

Phase 1/2 Withdrawn Novartis Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-11-15
Primary completion
2021-07-22
Completion
2023-06-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Midazolam Small molecule 2 mg/ml Oral
Subject Posaconazole Small molecule 100 mg Oral
Subject Siremadlin Small molecule 2.5 mg Oral
Subject Siremadlin Small molecule 10 mg Oral
Background Cytarabine Small molecule 20 mg Intravenous
Background Cytarabine Small molecule 1000 mg Intravenous
Background Daunorubicin Small molecule 20 mg Intravenous
Background Daunorubicin Small molecule 44 mg Intravenous
Background Daunorubicin Small molecule 100 mg Intravenous
Background Idarubicin Small molecule 20 mg Intravenous
Background Midostaurin Small molecule 25 mg Oral

Indications

acute myeloid leukemia