DS-3201b for Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |