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NCT01451632 · OUTCOME

Pharmacokinetic Parameters of MM-121

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
GEOMETRIC_MEAN
Unit
hr* ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121

What was measured

Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2)

Analysis population: Data presented by dose level of MM-121, regardless of the cohort (i.e. 15 patients in Part 1 were administered the 40/20 dose level of MM-121: 3 in cohort 3b, 4 in cohort 4, and 8 in the Part 1 expansion)

Groups in this outcome

Part 1: 12 mg/kg

MM-121 mg/kg plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2

Part 1: 20 mg/kg

MM-121: 20 mg/kg Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2

Part 1: 40/20 mg/kg

MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2

Part 2: 20 mg/kg

MM-121: 20 mg/kg plus cetuximab at 400/250 mg/m2 plus irinotecan at 180 mg/m2

Part 2: 40/20 mg/kg

MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses plus cetuximab 400/250 mg/m2 plus irinotecan 180 mg/m2

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: 12 mg/kg11
Part 1: 20 mg/kg8
Part 1: 40/20 mg/kg15
Part 2: 20 mg/kg10
Part 2: 40/20 mg/kg4

Reported measurements

Source class 1
Values in hr* ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: 12 mg/kg24190.522.0Not reportedNot reportedNot reported
Part 1: 20 mg/kg53063.146.1Not reportedNot reportedNot reported
Part 1: 40/20 mg/kg91111.939.9Not reportedNot reportedNot reported
Part 2: 20 mg/kg47681.514.2Not reportedNot reportedNot reported
Part 2: 40/20 mg/kg98387.716.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.0
        value
        24190.5
      2. group Id
        OG001
        spread
        46.1
        value
        53063.1
      3. group Id
        OG002
        spread
        39.9
        value
        91111.9
      4. group Id
        OG003
        spread
        14.2
        value
        47681.5
      5. group Id
        OG004
        spread
        16.2
        value
        98387.7
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      15
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      4
    units
    Participants
description
Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2)
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    MM-121 mg/kg plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
    id
    OG000
    title
    Part 1: 12 mg/kg
  2. description
    MM-121: 20 mg/kg Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
    id
    OG001
    title
    Part 1: 20 mg/kg
  3. description
    MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
    id
    OG002
    title
    Part 1: 40/20 mg/kg
  4. description
    MM-121: 20 mg/kg plus cetuximab at 400/250 mg/m2 plus irinotecan at 180 mg/m2
    id
    OG003
    title
    Part 2: 20 mg/kg
  5. description
    MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses plus cetuximab 400/250 mg/m2 plus irinotecan 180 mg/m2
    id
    OG004
    title
    Part 2: 40/20 mg/kg
param Type
GEOMETRIC_MEAN
population Description
Data presented by dose level of MM-121, regardless of the cohort (i.e. 15 patients in Part 1 were administered the 40/20 dose level of MM-121: 3 in cohort 3b, 4 in cohort 4, and 8 in the Part 1 expansion)
reporting Status
POSTED
time Frame
Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121
title
Pharmacokinetic Parameters of MM-121
type
SECONDARY
unit Of Measure
hr* ug/mL

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Preserved source evidence · Not medical advice