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NCT01587703 · OUTCOME

Duration of Response-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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Median of 1.41 months of drug exposure

What was measured

Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.

Analysis population: All Treated Population. Participants with incomplete response dates were excluded from the analysis.

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 NMC0
Participants With SCLC0
Participants With CRPC0
Participants With TNBC0
Participants With ER+BC0
Participants With GIST0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    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
      0
    6. group Id
      OG005
      value
      0
    units
    Participants
description
Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
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
population Description
All Treated Population. Participants with incomplete response dates were excluded from the analysis.
reporting Status
POSTED
time Frame
Median of 1.41 months of drug exposure
title
Duration of Response-Part 2
type
SECONDARY

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

Preserved source evidence · Not medical advice