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NCT01587703 · OUTCOME

Duration of Response-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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Median of 1.38 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

Part 1: GSK525762 2 mg QD

Participants were administered once daily (QD) oral dose of 2 milligrams (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 QD0
Part 1: GSK525762 4 mg QD0
Part 1: GSK525762 8 mg QD0
Part 1: GSK525762 16 mg QD0
Part 1: GSK525762 30 mg QD0
Part 1: GSK525762 60 mg QD0
Part 1: GSK525762 80 mg QD0
Part 1: GSK525762 100 mg QD0

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
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      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 were administered once daily (QD) oral dose of 2 milligrams (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
population Description
All Treated Population. Participants with incomplete response dates were excluded from the analysis.
reporting Status
POSTED
time Frame
Median of 1.38 months of drug exposure
title
Duration of Response-Part 1 QD
type
SECONDARY

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

Preserved source evidence · Not medical advice