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NCT02343120 · OUTCOME

Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of 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.

Measure
MEDIAN
Unit
Hours
Interval / dispersion
Full Range
Time frame
Week 2 Day 1 pre-dose and 24 hours

Analysis population: The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.

Groups in this outcome

Part 1: 40 mg QD

Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up

Part 1: 80 mg QD

Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up

Part 1: 160 mg QD

Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up

Part 1 and Part 2: 160 mg BID

Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.

Part 1 and Part 2: 320 mg QD

Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.

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

Analysis denominator · Participants

GroupSource count
Part 1: 40 mg QD3
Part 1: 80 mg QD4
Part 1: 160 mg QD5
Part 1 and Part 2: 160 mg BID77
Part 1 and Part 2: 320 mg QD72

Reported measurements

Source class 1
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: 40 mg QD2.00Not reported2.002.00Not reported
Part 1: 80 mg QD2.50Not reported1.083.00Not reported
Part 1: 160 mg QD2.00Not reported1.003.17Not reported
Part 1 and Part 2: 160 mg BID2.00Not reported0.536.00Not reported
Part 1 and Part 2: 320 mg QD2.00Not reported0.336.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.00
        upper Limit
        2.00
        value
        2.00
      2. group Id
        OG001
        lower Limit
        1.08
        upper Limit
        3.00
        value
        2.50
      3. group Id
        OG002
        lower Limit
        1.00
        upper Limit
        3.17
        value
        2.00
      4. group Id
        OG003
        lower Limit
        0.53
        upper Limit
        6.00
        value
        2.00
      5. group Id
        OG004
        lower Limit
        0.33
        upper Limit
        6.00
        value
        2.00
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      77
    5. group Id
      OG004
      value
      72
    units
    Participants
dispersion Type
Full Range
groups
  1. description
    Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
    id
    OG000
    title
    Part 1: 40 mg QD
  2. description
    Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
    id
    OG001
    title
    Part 1: 80 mg QD
  3. description
    Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
    id
    OG002
    title
    Part 1: 160 mg QD
  4. description
    Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
    id
    OG003
    title
    Part 1 and Part 2: 160 mg BID
  5. description
    Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
    id
    OG004
    title
    Part 1 and Part 2: 320 mg QD
param Type
MEDIAN
population Description
The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.
reporting Status
POSTED
time Frame
Week 2 Day 1 pre-dose and 24 hours
title
Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib
type
SECONDARY
unit Of Measure
Hours

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

Preserved source evidence · Not medical advice