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NCT03319537 · OUTCOME

Number of Patients Who Have a Clinical Benefit Rate (CBR) (Cohort 1)

Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma · Source last updated 2024-05-23

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
at 18 weeks post initiation of treatment

What was measured

The CBR is defined as the proportion of patients CR, PR or SD at 18 weeks based on RECIST criteria.

Analysis population: No participants accrued to pevonedistat in combination with pemetrexed and cisplatin cohort

Groups in this outcome

Pevonedistat

pevonedistat: Pevonedistat will be administered as an IV infusion at a dose of 50 mg/m2 days 1, 3, and 5 of a 21-day cycle.Treatment will be administered as an outpatient.

Pevonedistat in Combination With Pemetrexed and Cisplatin

pevonedistat: Pevonedistat will be administered as an IV infusion at a dose of 50 mg/m2 days 1, 3, and 5 of a 21-day cycle.Treatment will be administered as an outpatient. Pemetrexed and cisplatin: Pemetrexed, 500 mg/m2 and cisplatin, 75 mg/m2, will be given at fixed doses on day 1 of each cycle.

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

Analysis denominator · Participants

GroupSource count
Pevonedistat9
Pevonedistat in Combination With Pemetrexed and Cisplatin0

Reported measurements

Source class 1

Participants who have a Clinical Benefit Rate/CBR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pevonedistat2Not reportedNot reportedNot reportedNot reported

Participants without a Clinical Benefit Rate/CBR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pevonedistat7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      title
      Participants who have a Clinical Benefit Rate/CBR
    2. measurements
      1. group Id
        OG000
        value
        7
      title
      Participants without a Clinical Benefit Rate/CBR
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      0
    units
    Participants
description
The CBR is defined as the proportion of patients CR, PR or SD at 18 weeks based on RECIST criteria.
groups
  1. description
    pevonedistat: Pevonedistat will be administered as an IV infusion at a dose of 50 mg/m2 days 1, 3, and 5 of a 21-day cycle.Treatment will be administered as an outpatient.
    id
    OG000
    title
    Pevonedistat
  2. description
    pevonedistat: Pevonedistat will be administered as an IV infusion at a dose of 50 mg/m2 days 1, 3, and 5 of a 21-day cycle.Treatment will be administered as an outpatient. Pemetrexed and cisplatin: Pemetrexed, 500 mg/m2 and cisplatin, 75 mg/m2, will be given at fixed doses on day 1 of each cycle.
    id
    OG001
    title
    Pevonedistat in Combination With Pemetrexed and Cisplatin
param Type
COUNT_OF_PARTICIPANTS
population Description
No participants accrued to pevonedistat in combination with pemetrexed and cisplatin cohort
reporting Status
POSTED
time Frame
at 18 weeks post initiation of treatment
title
Number of Patients Who Have a Clinical Benefit Rate (CBR) (Cohort 1)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice