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NCT02860286 · OUTCOME

Part 1 and 2: To Evaluate the Duration of Response (DOR) in Subjects With Confirmed CR or PR

Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma · Source last updated 2021-04-09

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Every 6 weeks up to disease progression or start of new anti-cancer therapy assessed for up to 12 months

What was measured

DOR was calculated for subjects with a confirmed CR or PR. DOR is defined as the time from the date of the initial response (CR/PR) to the date of first documented PD or death due to any cause, whichever occurs first. DOR censoring rules followed those of the PFS analysis defined in the SAP. DOR was analyzed using the Kaplan-Meier methods and the median DOR, first quartile, and third quartile was presented. The associated 2- sided 95% CIs was estimated.

Groups in this outcome

Part 1

Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 statu

Part 2

Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma

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 113
Part 261

Reported measurements

DOR great than 6 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 10Not reportedNot reportedNot reportedNot reported
Part 20Not reportedNot reportedNot reportedNot reported
DOR great than 12 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 10Not reportedNot reportedNot reportedNot reported
Part 20Not reportedNot reportedNot reportedNot reported
DOR great than 18 weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 10Not reportedNot reportedNot reportedNot reported
Part 22Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    DOR great than 6 weeks
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    DOR great than 12 weeks
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    DOR great than 18 weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      61
    units
    Participants
description
DOR was calculated for subjects with a confirmed CR or PR. DOR is defined as the time from the date of the initial response (CR/PR) to the date of first documented PD or death due to any cause, whichever occurs first. DOR censoring rules followed those of the PFS analysis defined in the SAP. DOR was analyzed using the Kaplan-Meier methods and the median DOR, first quartile, and third quartile was presented. The associated 2- sided 95% CIs was estimated.
groups
  1. description
    Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 statu
    id
    OG000
    title
    Part 1
  2. description
    Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma
    id
    OG001
    title
    Part 2
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Every 6 weeks up to disease progression or start of new anti-cancer therapy assessed for up to 12 months
title
Part 1 and 2: To Evaluate the Duration of Response (DOR) in Subjects With Confirmed CR or PR
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice