Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04170283 | Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies | PHASE3 | ACTIVE NOT_RECRUITING | 955 | — | — | Jan 16, 2020 | Dec 1, 2028 | Oct 21, 2025 | 152 | United States, Australia +15 |
| NCT04551963 | Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies | PHASE1 | COMPLETED | 26 | — | — | Nov 15, 2020 | Feb 21, 2022 | Oct 26, 2024 | 7 | Australia |
| NCT02343120 | Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies | PHASE1 | COMPLETED | 385 | — | — | Sep 4, 2014 | Mar 31, 2021 | Apr 28, 2022 | 23 | United States, Australia +4 |
Safety as assessed by incidence of all treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)
Number of participants with adverse events and serious adverse events, including clinically relevant physical examinations and laboratory measurements
RP2D for zanubrutinib was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 320 mg QD
| Arm | Type | Description |
|---|---|---|
| Zanubrutinib (BGB-3111) | EXPERIMENTAL | All participants to receive open-label zanubrutinib |
| Zanubrutinib in combination with Tislelizumab | EXPERIMENTAL | Participants to receive the combination as in the parent study (Australia Only) |
| Arm A: Zanubrutinib with or without Moderate CYP3A | EXPERIMENTAL | Cycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day from Day 1 to Day 3; From Day 4 to Day 10, fluconazole was administered once a day at a dose of 400 mg with zanubrutinib at a reduced dose of 80 mg twice a day; On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg twice a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, diltiazem was administered once a day at a dose of 180 mg with 80 mg zanubrutinib twice a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg twice a day. Cycles 2 to 6 (28 days each cycle): Zanubrutinib 160 mg twice a day or 320 mg once a day. |
| Arm B: Zanubrutinib with or without Strong CYP3A | EXPERIMENTAL | Cycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day from Day 1 to Day 3; From Day 4 to Day 10, voriconazole was administered twice a day at a dose of 200 mg (total daily dose of 400 mg) with zanubrutinib at a reduced dose of 80 mg once a day; On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg once a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, clarithromycin was administered twice a day at a dose of 250 mg (total daily dose of 500 mg) with 80 mg zanubrutinib once a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg once a day. Cycles 2 to 6 (28 days each cycle): Zanubrutinib 160 mg twice a day or 320 mg once a day. |
| Zanubrutinib | EXPERIMENTAL | Participants were administered up to 320 mg total daily dose of zanubrutinib until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up |
| Name | Type | Description |
|---|---|---|
| Zanubrutinib | DRUG | Participants will receive zanubrutinib at a dose of 160 mg twice daily (for a total daily dose of 320 mg), or the last dose level received in the BeiGene parent study. |
| Tislelizumab | DRUG | Patients in Australia who participated in a parent study that involved combination therapy of zanubrutinib and tislelizumab will receive tislelizumab at a dose of 200mg every 3 weeks.. |
| Fluconazole | DRUG | Capsules administered at a dose and frequency as specified in the treatment arm |
| Diltiazem | DRUG | Capsules administered at a dose and frequency as specified in the treatment arm |
| Voriconazole | DRUG | Capsules administered at a dose and frequency as specified in the treatment arm |
| Clarithromycin | DRUG | Capsules administered at a dose and frequency as specified in the treatment arm |
1. Currently participating or participated recently in a BeiGene parent study 2. Intent to continue or start zanubrutinib treatment after any of the following: 1. At time of final analysis or study closure of the eligible BeiGene parent study 2. At time of progressive disease (PD); and invest...