Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02371369 · OUTCOME

Duration of Response (DOR) Based on RECIST 1.1

Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS) · Source last updated 2022-05-11

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Date of first documentation of objective response up to date of first documentation of progressive disease, assessed up to end of study (approximately 71 months)

What was measured

Duration of response (DOR) based on RECIST 1.1 is defined from the date of the first recorded evidence of response to the first date of documented disease progression.

Analysis population: DOR was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Pexidartinib Part 2 only. Participants randomized to Placebo Part 1 only were not analyzed. DOR was based on numbers of responders only.

Groups in this outcome

Pexidartinib Part 1 and Part 2

Part 1: Participants received treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Part 2: Participants also received pexidartinib at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration

Placebo Part 1, Pexidartinib Part 2

Participants that received placebo in part 1 and received Pexidartinib in Part 2 at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration

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

Analysis denominator · Participants

GroupSource count
Pexidartinib Part 1 and Part 237
Placebo Part 1, Pexidartinib Part 218

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pexidartinib Part 1 and Part 2NANot reported31.01NAMedian and upper limit 95% CI was not estimable due to insufficient number of events.
Placebo Part 1, Pexidartinib Part 2NANot reported39.0NAMedian and upper limit 95% CI was not estimable due to insufficient number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and upper limit 95% CI was not estimable due to insufficient number of events.
        group Id
        OG000
        lower Limit
        31.01
        upper Limit
        NA
        value
        NA
      2. comment
        Median and upper limit 95% CI was not estimable due to insufficient number of events.
        group Id
        OG001
        lower Limit
        39.0
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    2. group Id
      OG001
      value
      18
    units
    Participants
description
Duration of response (DOR) based on RECIST 1.1 is defined from the date of the first recorded evidence of response to the first date of documented disease progression.
dispersion Type
95% Confidence Interval
groups
  1. description
    Part 1: Participants received treatment of pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Part 2: Participants also received pexidartinib at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration
    id
    OG000
    title
    Pexidartinib Part 1 and Part 2
  2. description
    Participants that received placebo in part 1 and received Pexidartinib in Part 2 at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration
    id
    OG001
    title
    Placebo Part 1, Pexidartinib Part 2
param Type
MEDIAN
population Description
DOR was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Pexidartinib Part 2 only. Participants randomized to Placebo Part 1 only were not analyzed. DOR was based on numbers of responders only.
reporting Status
POSTED
time Frame
Date of first documentation of objective response up to date of first documentation of progressive disease, assessed up to end of study (approximately 71 months)
title
Duration of Response (DOR) Based on RECIST 1.1
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice