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NCT00701103 · OUTCOME

Mean Trough Serum Concentration (Ctrough) of Dalotuzumab

Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001) · Source last updated 2018-08-08

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

Measure
MEAN
Unit
ug/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-dose immediately prior to second infusion: 168 hours for Q1W, 336 hours for Q2W and 504 hours for Q3W dosing

What was measured

The lowest (trough) concentration of dalotuzumab prior to the next dose of dalotuzumab was measured.

Analysis population: The population consisted of all evaluable participants who received \>90% of intended drug volume and had mean trough serum concentration pharmacokinetic measurements at Baseline and at least once during treatment.

Groups in this outcome

Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)

Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.

Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)

Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.

Dalotuzumab 5 mg/kg Q1W (10 mg/mL)

Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.

Dalotuzumab 10 mg/kg Q1W (10 mg/mL)

Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.

Dalotuzumab 10 mg/kg Q1W (20 mg/mL)

Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.

Dalotuzumab 15 mg/kg Q1W (10 mg/mL)

Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.

Dalotuzumab 15 mg/kg Q1W (20 mg/mL)

Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.

Dalotuzumab 20 mg/kg Q1W (10 mg/mL)

Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.

Dalotuzumab 20 mg/kg Q1W (20 mg/mL)

Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.

Dalotuzumab 20 mg/kg Q2W (20 mg/mL)

Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.

Dalotuzumab 30 mg/kg Q3W (20 mg/mL)

Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.

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

Analysis denominator · Participants

GroupSource count
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)5
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)3
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)8
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)6
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)3
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)6
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)8
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)7
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)9
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)11
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)11

Reported measurements

Source class 1
Values in ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)2.42.2Not reportedNot reportedNot reported
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)7.23.0Not reportedNot reportedNot reported
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)21.28.3Not reportedNot reportedNot reported
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)54.813.3Not reportedNot reportedNot reported
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)45.217.4Not reportedNot reportedNot reported
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)81.238.6Not reportedNot reportedNot reported
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)59.617.3Not reportedNot reportedNot reported
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)110.546.0Not reportedNot reportedNot reported
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)87.341.5Not reportedNot reportedNot reported
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)57.022.7Not reportedNot reportedNot reported
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)70.434.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.2
        value
        2.4
      2. group Id
        OG001
        spread
        3.0
        value
        7.2
      3. group Id
        OG002
        spread
        8.3
        value
        21.2
      4. group Id
        OG003
        spread
        13.3
        value
        54.8
      5. group Id
        OG004
        spread
        17.4
        value
        45.2
      6. group Id
        OG005
        spread
        38.6
        value
        81.2
      7. group Id
        OG006
        spread
        17.3
        value
        59.6
      8. group Id
        OG007
        spread
        46.0
        value
        110.5
      9. group Id
        OG008
        spread
        41.5
        value
        87.3
      10. group Id
        OG009
        spread
        22.7
        value
        57.0
      11. group Id
        OG010
        spread
        34.1
        value
        70.4
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      8
    8. group Id
      OG007
      value
      7
    9. group Id
      OG008
      value
      9
    10. group Id
      OG009
      value
      11
    11. group Id
      OG010
      value
      11
    units
    Participants
description
The lowest (trough) concentration of dalotuzumab prior to the next dose of dalotuzumab was measured.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    OG000
    title
    Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
  2. description
    Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    OG001
    title
    Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
  3. description
    Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    OG002
    title
    Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
  4. description
    Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    OG003
    title
    Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
  5. description
    Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
    id
    OG004
    title
    Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
  6. description
    Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    OG005
    title
    Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
  7. description
    Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
    id
    OG006
    title
    Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
  8. description
    Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    OG007
    title
    Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
  9. description
    Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
    id
    OG008
    title
    Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
  10. description
    Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
    id
    OG009
    title
    Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
  11. description
    Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
    id
    OG010
    title
    Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
param Type
MEAN
population Description
The population consisted of all evaluable participants who received \>90% of intended drug volume and had mean trough serum concentration pharmacokinetic measurements at Baseline and at least once during treatment.
reporting Status
POSTED
time Frame
Pre-dose immediately prior to second infusion: 168 hours for Q1W, 336 hours for Q2W and 504 hours for Q3W dosing
title
Mean Trough Serum Concentration (Ctrough) of Dalotuzumab
type
PRIMARY
unit Of Measure
ug/mL

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

Preserved source evidence · Not medical advice