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NCT01587703 · OUTCOME

Number of Participants With PSA50 Response-Besylate Sub-study

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
NUMBER
Unit
Participants
Interval / dispersion
95% Confidence Interval
Time frame
Median of 1.87 months of drug exposure

What was measured

PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline \>=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA \>=50% reduction is presented along with 95% confidence intervals.

Analysis population: All Treated Population

Groups in this outcome

80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes

Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.

80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes

Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes5
80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes0Not reportedNANAConfidence interval could not be calculated as there were no responders
80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes0Not reportedNANAConfidence interval could not be calculated as there were no responders
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Confidence interval could not be calculated as there were no responders
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      2. comment
        Confidence interval could not be calculated as there were no responders
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      5
    units
    Participants
description
PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline \>=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA \>=50% reduction is presented along with 95% confidence intervals.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.
    id
    OG000
    title
    80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes
  2. description
    Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
    id
    OG001
    title
    80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
param Type
NUMBER
population Description
All Treated Population
reporting Status
POSTED
time Frame
Median of 1.87 months of drug exposure
title
Number of Participants With PSA50 Response-Besylate Sub-study
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice