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NCT02798536 · OUTCOME

Duration of Response (DOR)

Mesothelin-Targeted Immunotoxin LMB-100 in People With Malignant Mesothelioma · Source last updated 2022-08-23

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented by computed tomography (CT) scans performed every 6 weeks.

What was measured

The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

Groups in this outcome

Dose Level 1: 170mcg LMB-100

Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.

Dose Level -1: 140mcg LMB-100

Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.

Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel

Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.

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

Analysis denominator · Participants

GroupSource count
Dose Level 1: 170mcg LMB-1003
Dose Level -1: 140mcg LMB-1007
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel11

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Level 1: 170mcg LMB-100NANot reportedNANACriteria not met for CR or PR so DOR not calculated, data is not available.
Dose Level -1: 140mcg LMB-100NANot reportedNANACriteria not met for CR or PR so DOR not calculated, data is not available.
Dose Level -2: 100mcg LMB-100 + Nab-PaclitaxelNANot reportedNANACriteria not met for CR or PR so DOR not calculated, data is not available.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Criteria not met for CR or PR so DOR not calculated, data is not available.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Criteria not met for CR or PR so DOR not calculated, data is not available.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Criteria not met for CR or PR so DOR not calculated, data is not available.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      11
    units
    Participants
description
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
dispersion Type
Full Range
groups
  1. description
    Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.
    id
    OG000
    title
    Dose Level 1: 170mcg LMB-100
  2. description
    Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.
    id
    OG001
    title
    Dose Level -1: 140mcg LMB-100
  3. description
    Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
    id
    OG002
    title
    Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel
param Type
MEDIAN
reporting Status
POSTED
time Frame
time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented by computed tomography (CT) scans performed every 6 weeks.
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice