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NCT02371369 · OUTCOME

Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response to Pexidartinib Compared With That of Placebo Per Response Evaluation Criteria in Solid Tumors Version 1.1 at Week 25

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Week 25

What was measured

Complete response (CR) and partial responses (PR) were assessed based on centrally-read magnetic resonance imaging (MRI) scans and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference.

Analysis population: Best overall response was assessed in the Intent-to-Treat (ITT) population.

Groups in this outcome

Pexidartinib 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 Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.

Placebo Part 1

Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule 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 161
Placebo Part 159

Reported measurements

Complete Response (CR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pexidartinib Part 114.8Not reportedNot reportedNot reportedNot reported
Placebo Part 10Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pexidartinib Part 124.6Not reportedNot reportedNot reportedNot reported
Placebo Part 10Not reportedNot reportedNot reportedNot reported
Response (CR or PR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pexidartinib Part 139.3Not reportedNot reportedNot reportedNot reported
Placebo Part 10Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    Treatment comparison between the pexidartinib and placebo groups at Week 25
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Treatment comparison analysis
    non Inferiority Type
    OTHER
    p Value
    <0.0001
    statistical Method
    Fisher's Exact Test
Complete source fields
analyses
  1. group Description
    Treatment comparison between the pexidartinib and placebo groups at Week 25
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Treatment comparison analysis
    non Inferiority Type
    OTHER
    p Value
    <0.0001
    statistical Method
    Fisher's Exact Test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14.8
      2. group Id
        OG001
        value
        0
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        24.6
      2. group Id
        OG001
        value
        0
    title
    Partial Response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        39.3
      2. group Id
        OG001
        value
        0
    title
    Response (CR or PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    2. group Id
      OG001
      value
      59
    units
    Participants
description
Complete response (CR) and partial responses (PR) were assessed based on centrally-read magnetic resonance imaging (MRI) scans and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference.
groups
  1. description
    Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
    id
    OG000
    title
    Pexidartinib Part 1
  2. description
    Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.
    id
    OG001
    title
    Placebo Part 1
param Type
NUMBER
population Description
Best overall response was assessed in the Intent-to-Treat (ITT) population.
reporting Status
POSTED
time Frame
Week 25
title
Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response to Pexidartinib Compared With That of Placebo Per Response Evaluation Criteria in Solid Tumors Version 1.1 at Week 25
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice