Last updated on November 2019

A Study to Investigate BGB-3111 in Chinese Patients With B-cell Lymphoma

Brief description of study

This phase I clinical study is to investigate the safety, tolerability and pharmacokinetics/ pharmacodynamics of BTK inhibitor BGB-3111 in Chinese patients 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 BGB-3111 320 mg daily (160 mg BID, administered in the morning and at night, or 320 mg QD) and "3+3" design is adopted for the assessment. The recommended dose and method of administration of phase II clinical study will be determined according to the Part I results.

Part II: Dose expansion - this stage is to further evaluate the preliminary anti-tumor effects of BGB-3111 in Chinese subjects with follicular lymphoma (FL) or marginal zone lymphoma (MZL), approximately 20 subjects with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL) will be enrolled. The recommended Phase 2 dose will be used in the Part II.

Clinical Study Identifier: NCT03189524

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