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NCT02343120 · OUTCOME

Number of Participants With Greater Than 75% Bruton's Tyrosine Kinase (BTK) Occupancy

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Week 1 Day 1 (W1D1) predose, W1D1 4 hours, W1D2 24 hours, W1D3 predose, and W2D1 predose

What was measured

Number of participants with greater than 75% BTK occupancy of zanubrutinib in peripheral blood mononuclear cells (PBMCs)

Analysis population: Pharmacodynamic analysis set consisted of participants in which PBMCs were collected and evaluable samples were obtained.

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 were evaluated. 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 were evaluated. 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 BID21
Part 1 and Part 2: 320 mg QD10

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: 40 mg QD3Not reportedNot reportedNot reportedNot reported
Part 1: 80 mg QD4Not reportedNot reportedNot reportedNot reported
Part 1: 160 mg QD5Not reportedNot reportedNot reportedNot reported
Part 1 and Part 2: 160 mg BID20Not reportedNot reportedNot reportedNot reported
Part 1 and Part 2: 320 mg QD9Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        20
      5. group Id
        OG004
        value
        9
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
      21
    5. group Id
      OG004
      value
      10
    units
    Participants
description
Number of participants with greater than 75% BTK occupancy of zanubrutinib in peripheral blood mononuclear cells (PBMCs)
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 were evaluated. 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 were evaluated. 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
COUNT_OF_PARTICIPANTS
population Description
Pharmacodynamic analysis set consisted of participants in which PBMCs were collected and evaluable samples were obtained.
reporting Status
POSTED
time Frame
Week 1 Day 1 (W1D1) predose, W1D1 4 hours, W1D2 24 hours, W1D3 predose, and W2D1 predose
title
Number of Participants With Greater Than 75% Bruton's Tyrosine Kinase (BTK) Occupancy
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice