NCT02343120 · OUTCOME

Part 1: Recommended Phase 2 Dose (RP2D) for Zanubrutinib

Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies · Source last updated 2022-04-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

What was measured

RP2D for zanubrutinib was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 320 mg QD

Analysis population: The Safety Analysis Set included all participants who received ≥ 1 dose of study drug

Five dose regimens of zanubrutinib (40 mg QD, 80 mg QD, 160 mg QD, 160 mg BID, and 320 mg QD) were evaluated.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Part 1: Zanubrutinib	17

Source class 1

Values in milligrams · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: Zanubrutinib	320	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

denoms

description

RP2D for zanubrutinib was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 320 mg QD

groups

param Type

NUMBER

population Description

The Safety Analysis Set included all participants who received ≥ 1 dose of study drug

reporting Status

POSTED

time Frame

Month 9

title

Part 1: Recommended Phase 2 Dose (RP2D) for Zanubrutinib

type

PRIMARY

unit Of Measure

milligrams

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice