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NCT02798536 · OUTCOME

Recommended Phase 2 Dose (RP2D) of LMB100 + Nab-paclitaxel

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
NUMBER
Unit
mcg
Interval / dispersion
Not reported
Time frame
3 weeks after initial dose

What was measured

Highest administered dose of LMB-100 + nab-paclitaxel at which no more than 1 of 6 participants experiences a dose limiting toxicity (DLT). A DLT is any of the following events attributed to LMB-100 and occurring within 21 days after the first dose of LMB-100 such as Grade 4 neutropenia, Grade 3 and 4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia associated with bleeding episodes. Grade ≥ 3 non-hematological toxicity with the exception of alopecia (any grade), Grade 3 nausea and vomiting without appropriate treatment, Grade 3 diarrhea lasting for ≤ 2 days with no fever or dehydration.

Analysis population: Number of participants in the recommended Phase 2 (RP2D) of LMB-100 and the recommended Phase 2 Dose (RP2D) of LMB100 + Nab-paclitaxel are noted below.

Groups in this outcome

All Participants

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 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 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
All Participants21

Reported measurements

Recommended Phase 2 (RP2D) of LMB-100

Analysis denominator · Participants

GroupSource count
All Participants10
Values in mcg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants140Not reportedNot reportedNot reportedNot reported
Recommended Phase 2 Dose (RP2D) of LMB100 + Nab-paclitaxel

Analysis denominator · Participants

GroupSource count
All Participants11
Values in mcg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        140
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Recommended Phase 2 (RP2D) of LMB-100
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        100
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Recommended Phase 2 Dose (RP2D) of LMB100 + Nab-paclitaxel
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
Highest administered dose of LMB-100 + nab-paclitaxel at which no more than 1 of 6 participants experiences a dose limiting toxicity (DLT). A DLT is any of the following events attributed to LMB-100 and occurring within 21 days after the first dose of LMB-100 such as Grade 4 neutropenia, Grade 3 and 4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia associated with bleeding episodes. Grade ≥ 3 non-hematological toxicity with the exception of alopecia (any grade), Grade 3 nausea and vomiting without appropriate treatment, Grade 3 diarrhea lasting for ≤ 2 days with no fever or dehydration.
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. 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 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
    OG000
    title
    All Participants
param Type
NUMBER
population Description
Number of participants in the recommended Phase 2 (RP2D) of LMB-100 and the recommended Phase 2 Dose (RP2D) of LMB100 + Nab-paclitaxel are noted below.
reporting Status
POSTED
time Frame
3 weeks after initial dose
title
Recommended Phase 2 Dose (RP2D) of LMB100 + Nab-paclitaxel
type
PRIMARY
unit Of Measure
mcg

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

Preserved source evidence · Not medical advice