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NCT02860286 · OUTCOME

Part 1 and 2: Objective Response Rate (ORR; Complete Response + Partial Response [CR + 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
Assessed every 6 weeks for duration of study participation which is estimated to be 12 months

What was measured

ORR (confirmed CR+PR) to tazemetostat in subjects with relapsed/refractory malignant mesothelioma using disease-appropriate standardized response criteria (modified RECIST or RECIST 1.1)

Groups in this outcome

Part 1

Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status

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

Objective Response Rate,
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 10Not reportedNot reportedNot reportedNot reported
Part 22Not reportedNot reportedNot reportedNot reported
Complete response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 10Not reportedNot reportedNot reportedNot reported
Part 20Not reportedNot reportedNot reportedNot reported
Partial response
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
        2
    title
    Objective Response Rate,
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Complete response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Partial response
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      61
    units
    Participants
description
ORR (confirmed CR+PR) to tazemetostat in subjects with relapsed/refractory malignant mesothelioma using disease-appropriate standardized response criteria (modified RECIST or RECIST 1.1)
groups
  1. description
    Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status
    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
Assessed every 6 weeks for duration of study participation which is estimated to be 12 months
title
Part 1 and 2: Objective Response Rate (ORR; Complete Response + Partial Response [CR + PR])
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice