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NCT02798536 · OUTCOME

Median Progression Free Survival (PFS)

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
95% Confidence Interval
Time frame
At progression, up to 3.6 months

What was measured

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is 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: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 1: 170mcg LMB-1002.7Not reported2.73.0Not reported
Dose Level -1: 140mcg LMB-1002.7Not reported1.53.2Not reported
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel2.7Not reported1.33.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.7
        upper Limit
        3.0
        value
        2.7
      2. group Id
        OG001
        lower Limit
        1.5
        upper Limit
        3.2
        value
        2.7
      3. group Id
        OG002
        lower Limit
        1.3
        upper Limit
        3.6
        value
        2.7
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      11
    units
    Participants
description
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is 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
95% Confidence Interval
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
At progression, up to 3.6 months
title
Median Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice