NCT01451632 · OUTCOME

To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s) (Via Recording of Maximum Tolerated Dose (MTD)): MM-121 Doses

A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers · Source last updated 2016-09-08

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

Measure: NUMBER
Unit: mg/kg
Interval / dispersion: Not reported
Time frame: From date of first dose to 30 days after termination, the longest 48.1 weeks

What was measured

Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD Part 1: Cohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW Part 2: Cohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2

Analysis population: Number of patients participating in dose-escalation portion (excluding expansion cohort patients who were not evaluated for DLTs) MTD of cetuximab and irinotecan for the combination(s) are presented in a separate endpoint entry

Groups in this outcome

Part 1: MM-121 + Cetuximab

increasing doses of weekly MM-121 + weekly cetuximab MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)

Part 2: MM-121 + Cetuximab + Irinotecan

increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1 MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)

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
Part 1: MM-121 + Cetuximab	26
Part 2: MM-121 + Cetuximab + Irinotecan	10

Reported measurements

MM-121 loading dose

Values in mg/kg · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: MM-121 + Cetuximab	40	Not reported	Not reported	Not reported	Not reported
Part 2: MM-121 + Cetuximab + Irinotecan	NA	Not reported	Not reported	Not reported	The addition of the loading dose was determined to be a maximum tolerated dose, and is not included in the RP2D

MM-121 maintenance dose

Values in mg/kg · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: MM-121 + Cetuximab	20	Not reported	Not reported	Not reported	Not reported
Part 2: MM-121 + Cetuximab + Irinotecan	20	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
40
comment
The addition of the loading dose was determined to be a maximum tolerated dose, and is not included in the RP2D
group Id
OG001
value
NA
title
MM-121 loading dose
categories
measurements
group Id
OG000
value
20
group Id
OG001
value
20
title
MM-121 maintenance dose

denoms

counts
group Id
OG000
value
26
group Id
OG001
value
10
units
Participants

description

groups

description
increasing doses of weekly MM-121 + weekly cetuximab MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
id
OG000
title
Part 1: MM-121 + Cetuximab
description
increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1 MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV) Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
id
OG001
title
Part 2: MM-121 + Cetuximab + Irinotecan

param Type

NUMBER

population Description

Number of patients participating in dose-escalation portion (excluding expansion cohort patients who were not evaluated for DLTs) MTD of cetuximab and irinotecan for the combination(s) are presented in a separate endpoint entry

reporting Status

POSTED

time Frame

From date of first dose to 30 days after termination, the longest 48.1 weeks

title

To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s) (Via Recording of Maximum Tolerated Dose (MTD)): MM-121 Doses

type

PRIMARY

unit Of Measure

mg/kg

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Preserved source evidence · Not medical advice