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NCT01587703 · OUTCOME

Lambda z for GSK525762-Part 1 BID

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 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4

What was measured

Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose 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 20 mg BID

Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.

Part 1: GSK525762 30 mg BID

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

Part 1: GSK525762 40 mg BID

Participants were administered twice daily oral dose of 40 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 20 mg BID4
Part 1: GSK525762 30 mg BID10
Part 1: GSK525762 40 mg BID5

Reported measurements

Week1 AM dose;n=3,10,5

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 20 mg BID3
Part 1: GSK525762 30 mg BID10
Part 1: GSK525762 40 mg BID5
Values in Per hour · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BID0.2346319.4Not reportedNot reportedNot reported
Part 1: GSK525762 30 mg BID0.1998929.6Not reportedNot reportedNot reported
Part 1: GSK525762 40 mg BID0.2372139.4Not reportedNot reportedNot reported
Week1 PM dose;n=3,7,3

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 20 mg BID3
Part 1: GSK525762 30 mg BID7
Part 1: GSK525762 40 mg BID3
Values in Per hour · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BID0.2117123.1Not reportedNot reportedNot reported
Part 1: GSK525762 30 mg BID0.1430736.6Not reportedNot reportedNot reported
Part 1: GSK525762 40 mg BID0.1878925.2Not reportedNot reportedNot reported
Week3 AM dose;n=3,7,3

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 20 mg BID3
Part 1: GSK525762 30 mg BID7
Part 1: GSK525762 40 mg BID3
Values in Per hour · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BID0.2356527.2Not reportedNot reportedNot reported
Part 1: GSK525762 30 mg BID0.2175127.7Not reportedNot reportedNot reported
Part 1: GSK525762 40 mg BID0.3086819.6Not reportedNot reportedNot reported
Week3 PM dose;n=3,5,3

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 20 mg BID3
Part 1: GSK525762 30 mg BID5
Part 1: GSK525762 40 mg BID3
Values in Per hour · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BID0.2050721.5Not reportedNot reportedNot reported
Part 1: GSK525762 30 mg BID0.1926327.7Not reportedNot reportedNot reported
Part 1: GSK525762 40 mg BID0.2913315.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.4
        value
        0.23463
      2. group Id
        OG001
        spread
        29.6
        value
        0.19989
      3. group Id
        OG002
        spread
        39.4
        value
        0.23721
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    Week1 AM dose;n=3,10,5
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.1
        value
        0.21171
      2. group Id
        OG001
        spread
        36.6
        value
        0.14307
      3. group Id
        OG002
        spread
        25.2
        value
        0.18789
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Week1 PM dose;n=3,7,3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.2
        value
        0.23565
      2. group Id
        OG001
        spread
        27.7
        value
        0.21751
      3. group Id
        OG002
        spread
        19.6
        value
        0.30868
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Week3 AM dose;n=3,7,3
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.5
        value
        0.20507
      2. group Id
        OG001
        spread
        27.7
        value
        0.19263
      3. group Id
        OG002
        spread
        15.8
        value
        0.29133
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Week3 PM dose;n=3,5,3
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      5
    units
    Participants
description
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
    id
    OG000
    title
    Part 1: GSK525762 20 mg BID
  2. description
    Participants were administered twice daily oral dose of 30 mg GSK525762.
    id
    OG001
    title
    Part 1: GSK525762 30 mg BID
  3. description
    Participants were administered twice daily oral dose of 40 mg GSK525762.
    id
    OG002
    title
    Part 1: GSK525762 40 mg BID
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 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4
title
Lambda z for GSK525762-Part 1 BID
type
SECONDARY
unit Of Measure
Per hour

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice