A Phase 1 clinical study of nemtabrutinib in Japanese participants with hematological malignancies
- Conditions
- mature B-cell neoplasms
- Registration Number
- JPRN-jRCT2031220583
- Lead Sponsor
- Koh Yasuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
Histologically confirmed B-cell malignancy:
*Chronic lymphocytic leukemia (CLL)
*Small lymphocytic lymphoma (SLL)
*Waldenstrom'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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Dose limiting toxicities<br>- Adverse events(AEs)<br>- Discontinuing study treatment due to AEs
- Secondary Outcome Measures
Name Time Method - PK parameters including AUC, Cmax, Tmax and Cmin in plasma<br>- Objective response<br>- Duration of response