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NCT01587703 · OUTCOME

Number of Participants With Increase in QTcF-Part 2

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Median of 1.41 months of drug exposure

What was measured

ECG measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (\<450 milliseconds \[msec\]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (\>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.

Analysis population: All Treated Population. Only those participants with data available at the specified time point were analyzed.

Groups in this outcome

Participants With NMC

Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762

Participants With SCLC

Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762

Participants With CRPC

Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762

Participants With TNBC

Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762

Participants With ER+BC

Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762

Participants With GIST

Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 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
Participants With NMC11
Participants With SCLC14
Participants With CRPC22
Participants With TNBC19
Participants With ER+BC20
Participants With GIST12

Reported measurements

Any Grade increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With NMC1Not reportedNot reportedNot reportedNot reported
Participants With SCLC2Not reportedNot reportedNot reportedNot reported
Participants With CRPC6Not reportedNot reportedNot reportedNot reported
Participants With TNBC1Not reportedNot reportedNot reportedNot reported
Participants With ER+BC2Not reportedNot reportedNot reportedNot reported
Participants With GIST0Not reportedNot reportedNot reportedNot reported
Increase to Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With NMC0Not reportedNot reportedNot reportedNot reported
Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Participants With ER+BC2Not reportedNot reportedNot reportedNot reported
Participants With GIST0Not reportedNot reportedNot reportedNot reported
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With NMC1Not reportedNot reportedNot reportedNot reported
Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Participants With GIST0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
    title
    Any Grade increase
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
    title
    Increase to Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Increase to Grade 3
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      14
    3. group Id
      OG002
      value
      22
    4. group Id
      OG003
      value
      19
    5. group Id
      OG004
      value
      20
    6. group Id
      OG005
      value
      12
    units
    Participants
description
ECG measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (\<450 milliseconds \[msec\]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (\>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.
groups
  1. description
    Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762
    id
    OG000
    title
    Participants With NMC
  2. description
    Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762
    id
    OG001
    title
    Participants With SCLC
  3. description
    Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762
    id
    OG002
    title
    Participants With CRPC
  4. description
    Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762
    id
    OG003
    title
    Participants With TNBC
  5. description
    Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762
    id
    OG004
    title
    Participants With ER+BC
  6. description
    Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
    id
    OG005
    title
    Participants With GIST
param Type
COUNT_OF_PARTICIPANTS
population Description
All Treated Population. Only those participants with data available at the specified time point were analyzed.
reporting Status
POSTED
time Frame
Median of 1.41 months of drug exposure
title
Number of Participants With Increase in QTcF-Part 2
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice