Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Participants who received 100 mg DS-3201b administered orally to participants with AML or ALL.

Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.

Participants who received 250 mg DS-3201b administered orally to participants with AML or ALL.

Participants who received 500 mg DS-3201b administered orally to participants with AML or ALL.

Participants who received 700 mg DS-3201b administered orally to participants with AML or ALL.

DS-3201b is supplied as 25 and 100 mg capsules packaged in high-density polyethylene (HDPE) bottles.

DS-3201b

Global Clinical Leader

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.

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

A Phase 1 Study of DS-3201b in Subjects With Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Dose-limiting toxicity (DLT) is defined as a clinically significant non-hematologic treatment-emergent adverse event (TEAE) or abnormal clinical laboratory value that is clearly not related to disease progression, intercurrent illness, and occurring during the first cycle (28 days) on study that meets any of the following criteria: National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE), Version 4 Grade 3 aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), or bilirubin for ≥7 days; NCI-CTCAE Grade 4 AST (SGOT) or ALT (SGPT) of any duration; All Grade 4 non-hematologic toxicities of any duration; Any Grade 5 toxicity, unless proven to be clearly and incontrovertibly related to disease progression or intercurrent illness will constitute a DLT; All other clinically significant, non-hematological NCI-CTCAE Grade 3/4 AEs. AEs were coded using the MedDRA dictionary, Version 23.0.

A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug. AEs were coded using the MedDRA dictionary, Version 23.0.

Pharmacokinetic parameters were assessed using noncompartmental methods.

Blood samples were collected for PK analysis. PK parameters were assessed using noncompartmental methods.

Blood samples were collected for PK analysis. Area under the plasma concentration-time curve up to 24 hours (AUC24h) and area under the plasma concentration-time curve up to the last measurable concentration (AUClast) were assessed using noncompartmental methods.

Daiichi Sankyo

A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug or has worsened after initiating the study drug until 30 days after the last dose of the study drug.

DS-3201b 100mg

DS-3201b 150 mg

DS-3201b 250 mg

DS-3201b 500 mg

DS-3201b 700 mg

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

White

Black or African American

Asian

American Indian or Alaska Native

Native Hawaiian or Other Pacific Islander

Other

Race/Ethnicity, Customized

Demographic and baseline characteristics were assessed in the Safety Analysis Set.

Contact for Clinical Trial Information

Any TEAE classified as DLT, Any Grade

Gastrointestinal disorders, Any Grade

Diarrhea, Any Grade

Stomatitis, Any Grade

Blood and lymphatic system disorders, Any Grade

Bone marrow failure, Any Grade

Neoplasms benign, malignant, and unspecified (including cysts and polyps), Any Grade

Differentiation syndrome, Any Grade

Dose-limiting toxicities were assessed in the DLT Evaluable Set.

Number of Participants With Any Grade Treatment-emergent Adverse Event Classified as Dose-limiting Toxicities (Dose Escalation)

Treatment-emergent adverse events were assessed in the Safety Analysis Set.

Number of Participants Who Experienced Any Grade Treatment-emergent Adverse Event (Dose Escalation)

Cycle 1 Day 1

Cycle 1 Day 15

Cycle 1 Day 8

Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Pharmacokinetic Parameter Maximum (Peak) Observed Concentration (Cmax) of DS-3201b

Pharmacokinetic Parameter Time to Maximum Observed Concentration (Tmax) of DS-3201b

Cycle 1 Day 1: AUC24h

Cycle 1 Day 15: AUC24h

Cycle 1 Day 8: AUC24h

Cycle 1 Day 1: AUClast

Cycle 1 Day 15: AUClast

Cycle 1 Day 8: AUClast

Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.

Pharmacokinetic Parameter Area Under Plasma Concentration-Time Curve of DS-3201b

Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set in participants with available data.

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