NCT02798536 · OUTCOME

Number of Participants With LMB-100 Maximum Observed Serum Concentration (Cmax) of >100ng/mL

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Cycle 1 and Cycle 2 (each cycle is 21 days), approximately 42 days

What was measured

Number of participants with LMB-100 Maximum observed serum concentration (Cmax) of \>100ng/mL was measured by

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

Group	Source count
Dose Level 1: 170mcg LMB-100	3
Dose Level -1: 140mcg LMB-100	7
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel	11

Reported measurements

Cycle 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Level 1: 170mcg LMB-100	3	Not reported	Not reported	Not reported	Not reported
Dose Level -1: 140mcg LMB-100	7	Not reported	Not reported	Not reported	Not reported
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel	10	Not reported	Not reported	Not reported	Not reported

Cycle 2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Level 1: 170mcg LMB-100	2	Not reported	Not reported	Not reported	Not reported
Dose Level -1: 140mcg LMB-100	4	Not reported	Not reported	Not reported	Not reported
Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
3
group Id
OG001
value
7
group Id
OG002
value
10
title
Cycle 1
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
4
group Id
OG002
value
3
title
Cycle 2

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
7
group Id
OG002
value
11
units
Participants

description

Number of participants with LMB-100 Maximum observed serum concentration (Cmax) of \>100ng/mL was measured by

groups

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
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
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

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

Cycle 1 and Cycle 2 (each cycle is 21 days), approximately 42 days

title

Number of Participants With LMB-100 Maximum Observed Serum Concentration (Cmax) of >100ng/mL

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice