The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of nemtabrutinib in Japanese participants with mature B-cell neoplasms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Nemtabrutinib tablets will be administered orally QD at dosage of 45 mg or 65 mg
Nagoya University Hospital ( Site 0003)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 0002)
Kashiwa, Chiba, Japan
Kindai University Hospital ( Site 0006)
Sayama, Osaka, Japan
Chiba Cancer Center ( Site 0005)
Chiba, Japan
Number of Participants Who Experience Dose Limiting Toxicities (DLTs) Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
A DLT is ≥1 of: Grade ≥3 nonhematologic toxicity with exception of Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension lasting \>72 hours despite optimal supportive case; Grade 4 hematologic toxicity lasting \>7 days, Grade 4 platelet count decreased of any duration (with exceptions), or Grade 3 platelet count decreased with bleeding (with exceptions), or Grade 3 or higher febrile neutropenia of any duration; Grade 3 or Grade 4 nonhematologic laboratory abnormality, if results in drug induced liver injury (DILI), or medical intervention is required, or the abnormality leads to hospitalization, or the abnormality persists for \>1 week (with exceptions); missing \>25% of nemtabrutinib doses as a result of drug-related AE(s); Grade 5 toxicity. Toxicities will be graded using NCI-CTCAE version 5.0 except hematologic toxicities in participants with chronic lymphocytic leukemia (CLL) assessed according to the International Workshop on CLL (iwCLL) criteria.
Time frame: Up to approximately 4 weeks
Number of Participants Who Experience Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 26 months
Number of Participants Discontinuing Study Treatment Due to AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 26 months
Area Under the Curve From Dosing to 24 Hours Postdose (AUC0-24) of Nemtabrutinib
AUC0-24 is the area under the curve of plasma concentration of nemtabrutinib from dosing to 24 hours postdose.
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Kyushu University Hospital ( Site 0008)
Fukuoka, Japan
Okayama University Hospital ( Site 0007)
Okayama, Japan
Yamagata University Hospital ( Site 0001)
Yamagata, Japan
Time frame: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Minimum Concentration (Cmin) of Nemtabrutinib
Cmin is the lowest observed plasma concentration.
Time frame: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Maximum Concentration (Cmax) of Nemtabrutinib
Cmax is the lowest observed plasma concentration.
Time frame: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Time to Maximum Concentration (Tmax) of Nemtabrutinib
Tmax is the time to reach Cmax.
Time frame: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Objective Response Rate (ORR) as Assessed by Investigator
ORR is the proportion of participants in the analysis population with objective response. Objective response is defined as participants who achieve at least a partial response (PR) per disease-specific criteria as assessed by investigator. Data are presented separately for participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and non-CLL/SLL participants.
Time frame: Up to approximately 26 months
Duration of Response (DOR) as Assessed by Investigator
For participants who demonstrate an objective response as assessed by investigator, per disease-specific criteria, duration of response is defined as the time from the first documented evidence of an objective response until disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 26 months