A Phase 1 Clinical Study of Nemtabrutinib (MK-1026) in Japanese Participants With Hematological Malignancies (BELLWAVE-002)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 14
- 主要终点
- Number of Participants who Experience Adverse Events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion and
排除标准
- •include but are not limited to the following:
- •Inclusion Criteria:
- •Histologically confirmed B-cell malignancy:
- •Chronic lymphocytic leukemia (CLL)
- •Small lymphocytic lymphoma (SLL)
- •Waldenström's macroglobulinemia (WM)
- •Lymphoplasmacytic lymphoma (LPL)
- •Other B-cell neoplasm
- •Failed or intolerant to either at least 2 prior regimens given in combination or sequentially OR have received 1 prior Bruton's tyrosine kinase (BTK)-containing regimen when a BTK inhibitor is approved as first line therapy
- •Have the ability to swallow and retain oral medication
- •Is Japanese
- •Exclusion Criteria:
- •Active Hepatitis B virus (HBV)/Hepatitis C virus (HCV) infection at study entry
- •History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
- •Known history of human immunodeficiency virus (HIV) infection
- •Clinically significant gastrointestinal abnormalities that might alter absorption (eg, gastric bypass surgery, gastrectomy)
- •Underlying history of severe bleeding disorders
- •History or concurrent condition of pneumonitis/interstitial lung disease
研究组 & 干预措施
Nemtabrutinib
Participants receive nemtabrutinib at specified dose orally once daily (QD) until progressive disease (PD) or discontinuation
干预措施: Nemtabrutinib (Drug)
结局指标
主要结局
Number of Participants who Experience Adverse Events (AEs)
时间窗: Up to approximately 38 months
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.
Number of Participants who Experience Dose Limiting Toxicities (DLTs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
时间窗: Up to approximately 4 weeks
A DLT consists of one or more of the following toxicities: Grade ≥3 nonhematologic toxicity with exception of Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension; 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, or Grade 3 or higher febrile neutropenia of any duration; Grade 3 or Grade 4 nonhematologic laboratory abnormality, if values result 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.
Number of Participants Discontinuing Study Treatment due to AEs
时间窗: Up to approximately 38 months
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.
次要结局
- Area under the Curve (AUC) of Nemtabrutinib(Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, 10, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 and 4 hours post-dose (up to ~57 days). Each cycle is 28 days)
- Time to Maximum Concentration (Tmax) of Nemtabrutinib(Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, 10, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 and 4 hours post-dose (up to ~57 days). Each cycle is 28 days)
- Objective Response Rate (ORR) as Assessed by Investigator(Up to approximately 38 months)
- Duration of Response (DOR) as Assessed by Investigator(Up to approximately 38 months)
- Maximum Concentration (Cmax) of Nemtabrutinib(Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, 10, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 and 4 hours post-dose (up to ~57 days). Each cycle is 28 days)
- Minimum Concentration (Cmin) of Nemtabrutinib(Day 1 of Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 and 4 hours post-dose (up to ~57 days). Each cycle is 28 days)