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NCT01587703 · OUTCOME

Overall Response Rate-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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Median of 1.38 months of drug exposure

What was measured

Overall response rate is defined as the percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST version (v) 1.1). CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Analysis population: All Treated Population

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 QD3
Part 1: GSK525762 4 mg QD4
Part 1: GSK525762 8 mg QD1
Part 1: GSK525762 16 mg QD3
Part 1: GSK525762 30 mg QD4
Part 1: GSK525762 60 mg QD9
Part 1: GSK525762 80 mg QD32
Part 1: GSK525762 100 mg QD9

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 2 mg QD0Not reported0.070.8Not reported
Part 1: GSK525762 4 mg QD25Not reported0.680.6Not reported
Part 1: GSK525762 8 mg QD0Not reported0.097.5Not reported
Part 1: GSK525762 16 mg QD0Not reported0.070.8Not reported
Part 1: GSK525762 30 mg QD0Not reported0.060.2Not reported
Part 1: GSK525762 60 mg QD0Not reported0.033.6Not reported
Part 1: GSK525762 80 mg QD3Not reported0.116.2Not reported
Part 1: GSK525762 100 mg QD11Not reported0.348.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        70.8
        value
        0
      2. group Id
        OG001
        lower Limit
        0.6
        upper Limit
        80.6
        value
        25
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        97.5
        value
        0
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        70.8
        value
        0
      5. group Id
        OG004
        lower Limit
        0.0
        upper Limit
        60.2
        value
        0
      6. group Id
        OG005
        lower Limit
        0.0
        upper Limit
        33.6
        value
        0
      7. group Id
        OG006
        lower Limit
        0.1
        upper Limit
        16.2
        value
        3
      8. group Id
        OG007
        lower Limit
        0.3
        upper Limit
        48.2
        value
        11
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      9
    7. group Id
      OG006
      value
      32
    8. group Id
      OG007
      value
      9
    units
    Participants
description
Overall response rate is defined as the percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST version (v) 1.1). CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
dispersion Type
95% Confidence Interval
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
param Type
NUMBER
population Description
All Treated Population
reporting Status
POSTED
time Frame
Median of 1.38 months of drug exposure
title
Overall Response Rate-Part 1 QD
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice