A Study to Investigate Zanubrutinib in Chinese Participants With B-cell Lymphoma
Status:
Completed
Trial end date:
2020-08-26
Target enrollment:
Participant gender:
Summary
This phase I clinical study was to investigate the safety, tolerability, and
pharmacokinetics/pharmacodynamics of Bruton tyrosine kinase (BTK) inhibitor zanubrutinib
(BGB-3111) in Chinese participants with B-cell lymphoma by conducting in two stages, the
first stage being the safety assessment of dose and the second stage being the dose
expansion.
Part I: Safety evaluation - according to the results of preclinical toxicological trials and
the results of the phase I clinical study conducted in Australia and New Zealand, two
regimens of zanubrutinib 320 milligrams (mg) daily (160 mg twice daily [BID]), administered
in the morning and at night, or 320 mg once daily [QD]) and "3+3" design was adopted for the
assessment. The recommended dose and method of administration of the phase II clinical study
was determined according to the Part I results.
Part II: Dose expansion - this stage was to further evaluate the preliminary anti-tumor
effects of zanubrutinib in Chinese participants with follicular lymphoma (FL) or marginal
zone lymphoma (MZL), approximately 20 participants with relapsed or refractory FL or MZL were
to be enrolled. The recommended Phase 2 dose (RP2D) was used in Part II.