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A Clinical Study of Nemtabrutinib in Japanese Participants With Hematological Malignancies (MK-1026-002)

CompletedPhase 1

Sponsor: Merck Sharp & Dohme LLC

Conditions: Mature B-cell Neoplasms

Interventions: Nemtabrutinib

Countries: Japan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

The main inclusion and exclusion criteria 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

Locations (7)

Nagoya, Aichi-ken, Japan
Kashiwa, Chiba, Japan
Sayama, Osaka, Japan
Chiba, Japan
Fukuoka, Japan
Okayama, Japan
Yamagata, Japan