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NCT01587703 · OUTCOME

Overall Survival-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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Median of 1.41 months of drug exposure

What was measured

Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.

Analysis population: All Treated Population

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 NMC12
Participants With SCLC14
Participants With CRPC23
Participants With TNBC19
Participants With ER+BC21
Participants With GIST13

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Participants With NMC5.0Not reported4.3NAThe upper limit of the 95% CI could not be estimated due to the low number of participants being analyzed.
Participants With SCLC2.6Not reported1.19.4Not reported
Participants With CRPC9.1Not reported6.711.7Not reported
Participants With TNBC5.0Not reported2.310.3Not reported
Participants With ER+BC8.8Not reported3.613.1Not reported
Participants With GIST7.3Not reported3.4NAThe upper limit of the 95% CI could not be estimated due to the low number of participants being analyzed.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of the 95% CI could not be estimated due to the low number of participants being analyzed.
        group Id
        OG000
        lower Limit
        4.3
        upper Limit
        NA
        value
        5.0
      2. group Id
        OG001
        lower Limit
        1.1
        upper Limit
        9.4
        value
        2.6
      3. group Id
        OG002
        lower Limit
        6.7
        upper Limit
        11.7
        value
        9.1
      4. group Id
        OG003
        lower Limit
        2.3
        upper Limit
        10.3
        value
        5.0
      5. group Id
        OG004
        lower Limit
        3.6
        upper Limit
        13.1
        value
        8.8
      6. comment
        The upper limit of the 95% CI could not be estimated due to the low number of participants being analyzed.
        group Id
        OG005
        lower Limit
        3.4
        upper Limit
        NA
        value
        7.3
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      14
    3. group Id
      OG002
      value
      23
    4. group Id
      OG003
      value
      19
    5. group Id
      OG004
      value
      21
    6. group Id
      OG005
      value
      13
    units
    Participants
description
Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
All Treated Population
reporting Status
POSTED
time Frame
Median of 1.41 months of drug exposure
title
Overall Survival-Part 2
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice