Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01451632 · OUTCOME

Objective Response Rate

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
participants with objective response
Interval / dispersion
Not reported
Time frame
Patients were assessed for objective response from time of first dose through treatment termination, the longest treatment duration being 48.1 weeks

What was measured

To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as \>20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.

Groups in this outcome

Part 1: Cohort 1

MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses

Part 1: Cohort 2a

MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW

Part 1: Cohort 2b

MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW

Part 1: Cohort 3a

MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW

Part 1: Cohort 3b

MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW

Part 1: Cohort 4

MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW

Part 1: Expansion Cohort

MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW

Part 2: Cohort 1

MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W

Part 2: Cohort 2

MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W

Part 2: Expansion Cohort

MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W

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

Analysis denominator · Participants

GroupSource count
Part 1: Cohort 18
Part 1: Cohort 2a4
Part 1: Cohort 2b3
Part 1: Cohort 3a3
Part 1: Cohort 3b4
Part 1: Cohort 44
Part 1: Expansion Cohort8
Part 2: Cohort 16
Part 2: Cohort 24
Part 2: Expansion Cohort4

Reported measurements

Source class 1
Values in participants with objective response · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Cohort 11Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2a0Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2b0Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 3a0Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 3b0Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 40Not reportedNot reportedNot reportedNot reported
Part 1: Expansion Cohort1Not reportedNot reportedNot reportedNot reported
Part 2: Cohort 11Not reportedNot reportedNot reportedNot reported
Part 2: Cohort 20Not reportedNot reportedNot reportedNot reported
Part 2: Expansion Cohort0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      8
    8. group Id
      OG007
      value
      6
    9. group Id
      OG008
      value
      4
    10. group Id
      OG009
      value
      4
    units
    Participants
description
To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as \>20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.
groups
  1. description
    MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
    id
    OG000
    title
    Part 1: Cohort 1
  2. description
    MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
    id
    OG001
    title
    Part 1: Cohort 2a
  3. description
    MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
    id
    OG002
    title
    Part 1: Cohort 2b
  4. description
    MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
    id
    OG003
    title
    Part 1: Cohort 3a
  5. description
    MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
    id
    OG004
    title
    Part 1: Cohort 3b
  6. description
    MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
    id
    OG005
    title
    Part 1: Cohort 4
  7. description
    MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
    id
    OG006
    title
    Part 1: Expansion Cohort
  8. description
    MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
    id
    OG007
    title
    Part 2: Cohort 1
  9. description
    MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
    id
    OG008
    title
    Part 2: Cohort 2
  10. description
    MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
    id
    OG009
    title
    Part 2: Expansion Cohort
param Type
NUMBER
reporting Status
POSTED
time Frame
Patients were assessed for objective response from time of first dose through treatment termination, the longest treatment duration being 48.1 weeks
title
Objective Response Rate
type
SECONDARY
unit Of Measure
participants with objective response

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

Preserved source evidence · Not medical advice