Trials / Completed
CompletedNCT03189524
A Study to Investigate Zanubrutinib in Chinese Participants With B-cell Lymphoma
A Phase I Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of BTK Inhibitor BGB-3111 in Chinese Patients With B-cell Lymphoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zanubrutinib | Zanubrutinib is a white to off-white solid that is slightly hygroscopic. The drug product was formulated as 20-mg (blue, size 3) and 80-mg (white, size 0) hard gelatin, opaque oral capsules. Zanubrutinib is classified as a Biopharmaceutics Classification System Class II compound. |
Timeline
- Start date
- 2016-07-05
- Primary completion
- 2020-08-26
- Completion
- 2020-08-26
- First posted
- 2017-06-16
- Last updated
- 2024-12-27
- Results posted
- 2021-10-22
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03189524. Inclusion in this directory is not an endorsement.