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NCT01587703 · OUTCOME

Lambda z for GSK525762-Part 1 QD

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers · Source last updated 2020-03-16

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

Measure
GEOMETRIC_MEAN
Unit
Per hour
Interval / dispersion
Geometric Coefficient of Variation
Time frame
pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4

What was measured

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.

Analysis population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Groups in this outcome

Part 1: GSK525762 2 mg QD

Participants were administered once daily oral dose of 2 mg GSK525762.

Part 1: GSK525762 4 mg QD

Participants were administered once daily oral dose of 4 mg GSK525762.

Part 1: GSK525762 8 mg QD

Participants were administered once daily oral dose of 8 mg GSK525762.

Part 1: GSK525762 16 mg QD

Participants were administered once daily oral dose of 16 mg GSK525762.

Part 1: GSK525762 30 mg QD

Participants were administered once daily oral dose of 30 mg GSK525762.

Part 1: GSK525762 60 mg QD

Participants were administered once daily oral dose of 60 mg GSK525762.

Part 1: GSK525762 80 mg QD

Participants were administered once daily oral dose of 80 mg GSK525762.

Part 1: GSK525762 100 mg QD

Participants were administered once daily oral dose of 100 mg GSK525762.

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: GSK525762 2 mg QD3
Part 1: GSK525762 4 mg QD4
Part 1: GSK525762 8 mg QD1
Part 1: GSK525762 16 mg QD3
Part 1: GSK525762 30 mg QD4
Part 1: GSK525762 60 mg QD9
Part 1: GSK525762 80 mg QD32
Part 1: GSK525762 100 mg QD9

Reported measurements

Week1;n=3,4,1,3,4,9,32,9

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 2 mg QD3
Part 1: GSK525762 4 mg QD4
Part 1: GSK525762 8 mg QD1
Part 1: GSK525762 16 mg QD3
Part 1: GSK525762 30 mg QD4
Part 1: GSK525762 60 mg QD9
Part 1: GSK525762 80 mg QD32
Part 1: GSK525762 100 mg QD9
Values in Per hour · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 2 mg QD0.2141198.4Not reportedNot reportedNot reported
Part 1: GSK525762 4 mg QD0.1355437.4Not reportedNot reportedNot reported
Part 1: GSK525762 8 mg QD0.23126NANot reportedNot reportedGeometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
Part 1: GSK525762 16 mg QD0.0990343.5Not reportedNot reportedNot reported
Part 1: GSK525762 30 mg QD0.0786353.1Not reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD0.1246828.2Not reportedNot reportedNot reported
Part 1: GSK525762 80 mg QD0.1561334.1Not reportedNot reportedNot reported
Part 1: GSK525762 100 mg QD0.1099216.0Not reportedNot reportedNot reported
Week3;n=1,2,1,3,4,6,16,6

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 2 mg QD1
Part 1: GSK525762 4 mg QD2
Part 1: GSK525762 8 mg QD1
Part 1: GSK525762 16 mg QD3
Part 1: GSK525762 30 mg QD4
Part 1: GSK525762 60 mg QD6
Part 1: GSK525762 80 mg QD16
Part 1: GSK525762 100 mg QD6
Values in Per hour · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 2 mg QD0.15579NANot reportedNot reportedGeometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
Part 1: GSK525762 4 mg QD0.1547211.2Not reportedNot reportedNot reported
Part 1: GSK525762 8 mg QD0.14087NANot reportedNot reportedGeometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
Part 1: GSK525762 16 mg QD0.1559921.7Not reportedNot reportedNot reported
Part 1: GSK525762 30 mg QD0.1251312.7Not reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD0.1762926.3Not reportedNot reportedNot reported
Part 1: GSK525762 80 mg QD0.1666730.6Not reportedNot reportedNot reported
Part 1: GSK525762 100 mg QD0.1756021.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        98.4
        value
        0.21411
      2. group Id
        OG001
        spread
        37.4
        value
        0.13554
      3. comment
        Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
        group Id
        OG002
        spread
        NA
        value
        0.23126
      4. group Id
        OG003
        spread
        43.5
        value
        0.09903
      5. group Id
        OG004
        spread
        53.1
        value
        0.07863
      6. group Id
        OG005
        spread
        28.2
        value
        0.12468
      7. group Id
        OG006
        spread
        34.1
        value
        0.15613
      8. group Id
        OG007
        spread
        16.0
        value
        0.10992
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        9
      7. group Id
        OG006
        value
        32
      8. group Id
        OG007
        value
        9
      units
      Participants
    title
    Week1;n=3,4,1,3,4,9,32,9
  2. categories
    1. measurements
      1. comment
        Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
        group Id
        OG000
        spread
        NA
        value
        0.15579
      2. group Id
        OG001
        spread
        11.2
        value
        0.15472
      3. comment
        Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
        group Id
        OG002
        spread
        NA
        value
        0.14087
      4. group Id
        OG003
        spread
        21.7
        value
        0.15599
      5. group Id
        OG004
        spread
        12.7
        value
        0.12513
      6. group Id
        OG005
        spread
        26.3
        value
        0.17629
      7. group Id
        OG006
        spread
        30.6
        value
        0.16667
      8. group Id
        OG007
        spread
        21.1
        value
        0.17560
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        6
      7. group Id
        OG006
        value
        16
      8. group Id
        OG007
        value
        6
      units
      Participants
    title
    Week3;n=1,2,1,3,4,6,16,6
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      9
    7. group Id
      OG006
      value
      32
    8. group Id
      OG007
      value
      9
    units
    Participants
description
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants were administered once daily oral dose of 2 mg GSK525762.
    id
    OG000
    title
    Part 1: GSK525762 2 mg QD
  2. description
    Participants were administered once daily oral dose of 4 mg GSK525762.
    id
    OG001
    title
    Part 1: GSK525762 4 mg QD
  3. description
    Participants were administered once daily oral dose of 8 mg GSK525762.
    id
    OG002
    title
    Part 1: GSK525762 8 mg QD
  4. description
    Participants were administered once daily oral dose of 16 mg GSK525762.
    id
    OG003
    title
    Part 1: GSK525762 16 mg QD
  5. description
    Participants were administered once daily oral dose of 30 mg GSK525762.
    id
    OG004
    title
    Part 1: GSK525762 30 mg QD
  6. description
    Participants were administered once daily oral dose of 60 mg GSK525762.
    id
    OG005
    title
    Part 1: GSK525762 60 mg QD
  7. description
    Participants were administered once daily oral dose of 80 mg GSK525762.
    id
    OG006
    title
    Part 1: GSK525762 80 mg QD
  8. description
    Participants were administered once daily oral dose of 100 mg GSK525762.
    id
    OG007
    title
    Part 1: GSK525762 100 mg QD
param Type
GEOMETRIC_MEAN
population Description
PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
reporting Status
POSTED
time Frame
pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4
title
Lambda z for GSK525762-Part 1 QD
type
SECONDARY
unit Of Measure
Per hour

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Preserved source evidence · Not medical advice