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NCT01943851 · OUTCOME

Part 2: Progression Free Survival (PFS)

A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies · Source last updated 2024-10-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
Inter-Quartile Range
Time frame
Up to 36.4 weeks

What was measured

PFS defined as interval of time(in months) between date of first dose \& earlier of date of disease progression \& date of death due to any cause.Progression is participants(pt's)with MDS \& with \<5% blasts:\>=50% increase in blasts to\>5% blasts/pt's with 5-10% blasts:\>=50% increase to \>10% blasts, for pt's with 10-20% blasts:\>=50% increase to \>20% blasts,for pt's with 20%-30% blasts:\>=50% increase to \>30% blasts, for CTCL progression is \>=25% increase in skin disease from Baseline/new tumors (T3\[1 or more tumors(\>=1cm diameter\]) in pt's with T1(Limited patches,papules\&/or plaques covering \<10% of the skin surface;may further stratify into T1a \[patch only\] versus T1b \[plaque+-patch\]),T2(Patches,papules/plaques covering \>=10% of skin surface;may further stratify into T2a\[patch only\]versus T2b \[plaque+-patch\]) orT4(Confluence of erythema covering \>=80% body surface area) only skin disease/loss of response in those with CR/PR, increase of skin score of \> sum of nadir +50% Baseline score.

Analysis population: All Treated Population.

Groups in this outcome

Part 2: GSK525762 60 mg QD CTCL

Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.

Part 2: GSK525762 75 mg QD MDS

Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762

Part 2: GSK525762 80 mg QD CTCL

Participants CTCL were administered once daily oral dose of 80 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 2: GSK525762 60 mg QD CTCL7
Part 2: GSK525762 75 mg QD MDS16
Part 2: GSK525762 80 mg QD CTCL1

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Part 2: GSK525762 60 mg QD CTCL8.15Not reported3.48NAThird quartile could not be calculated
Part 2: GSK525762 75 mg QD MDS2.00Not reported1.453.48Not reported
Part 2: GSK525762 80 mg QD CTCLNANot reportedNANANo event occurred for single participant hence Median and Inter-quartile range could not be calculated
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Third quartile could not be calculated
        group Id
        OG000
        lower Limit
        3.48
        upper Limit
        NA
        value
        8.15
      2. group Id
        OG001
        lower Limit
        1.45
        upper Limit
        3.48
        value
        2.00
      3. comment
        No event occurred for single participant hence Median and Inter-quartile range could not be calculated
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      1
    units
    Participants
description
PFS defined as interval of time(in months) between date of first dose \& earlier of date of disease progression \& date of death due to any cause.Progression is participants(pt's)with MDS \& with \<5% blasts:\>=50% increase in blasts to\>5% blasts/pt's with 5-10% blasts:\>=50% increase to \>10% blasts, for pt's with 10-20% blasts:\>=50% increase to \>20% blasts,for pt's with 20%-30% blasts:\>=50% increase to \>30% blasts, for CTCL progression is \>=25% increase in skin disease from Baseline/new tumors (T3\[1 or more tumors(\>=1cm diameter\]) in pt's with T1(Limited patches,papules\&/or plaques covering \<10% of the skin surface;may further stratify into T1a \[patch only\] versus T1b \[plaque+-patch\]),T2(Patches,papules/plaques covering \>=10% of skin surface;may further stratify into T2a\[patch only\]versus T2b \[plaque+-patch\]) orT4(Confluence of erythema covering \>=80% body surface area) only skin disease/loss of response in those with CR/PR, increase of skin score of \> sum of nadir +50% Baseline score.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
    id
    OG000
    title
    Part 2: GSK525762 60 mg QD CTCL
  2. description
    Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
    id
    OG001
    title
    Part 2: GSK525762 75 mg QD MDS
  3. description
    Participants CTCL were administered once daily oral dose of 80 mg GSK525762
    id
    OG002
    title
    Part 2: GSK525762 80 mg QD CTCL
param Type
MEDIAN
population Description
All Treated Population.
reporting Status
POSTED
time Frame
Up to 36.4 weeks
title
Part 2: Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice