drugset / Trial / NCT03110354

DS-3201b for Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)

NCT03110354

Phase 1 Terminated 28 enrolled Daiichi Sankyo
Non-randomizedSequentialOpen-labelTreatment

Summary

This research study tests an investigational drug called DS-3201b. An investigational drug is a medication that is still being studied and has not yet been approved by the United States Food and Drug Administration (FDA). The FDA allows DS-3201b to be used only in research. It is not known if DS-3201b will work or not. This study consists of two parts. The first part (Part 1) is a dose escalation that will enroll subjects with AML or ALL that did not respond or no longer respond to previous standard therapy. The purpose of Part 1 of this research study is to determine the highest dose a patient can tolerate or recommended dose of DS-3201b that can be given to subjects with AML or ALL. Once the highest tolerable dose is determined, additional subjects will be enrolled at that dose into Part 2 of the study.

Timeline

Start
2017-04-05
Primary completion
2021-03-09
Completion
2021-03-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Valemetostat Small molecule 100 mg Oral
Subject Valemetostat Small molecule 150 mg Oral
Subject Valemetostat Small molecule 250 mg Oral
Subject Valemetostat Small molecule 500 mg Oral
Subject Valemetostat Small molecule 700 mg Oral