Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies
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|ClinicalTrials.gov Identifier: NCT02343120|
Recruitment Status : Active, not recruiting
First Posted : January 21, 2015
Last Update Posted : March 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|B-cell Malignancies||Drug: BGB-3111||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||397 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects With B-Cell Lymphoid Malignancies|
|Actual Study Start Date :||November 26, 2014|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||January 2022|
All patients will undertake 160MG BID of BGB-3111.
In the dose-escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.
In the safety, schedule and efficacy expansion part, patients will be assigned to different cohorts based on histology type.
- Number of participants with adverse events [ Time Frame: From first dose to within 28 days of last dose of BGB-3111 ]Creating a safety profile
- Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast) [ Time Frame: During first 2 weeks ]
- Area under the plasma concentration-time curve from time 0 to infinity time (AUC∞) [ Time Frame: During first 2 weeks ]
- Maximum plasma concentration (Cmax) [ Time Frame: During first 2 weeks ]
- Time to reach maximum plasma concentration (tmax) [ Time Frame: During first 2 weeks ]
- Terminal elimination half-life (t1/2) [ Time Frame: During first 2 weeks ]
- BTK inhibition activity of BGB-3111 by measurement of free BTK [ Time Frame: During first 2 weeks ]
- Tumor response [ Time Frame: Every 12 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343120
|Principal Investigator:||Constantine Tam, MD||Peter MacCallum Cancer Centre, Australia|