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NCT00701103 · OUTCOME

Change From Baseline in Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Expression Level H-score in Skin Samples

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
H-score
Interval / dispersion
Standard Deviation
Time frame
Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)

What was measured

IGF-1R expression was measured in pre- and post-dose skin biopsy samples using an immunohistochemistry (IHC) assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.

Analysis population: The population consisted of all evaluable participants who received \>90% of intended drug volume and had skin IGF-1R pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 30 mg/kg Q3W treatment group.

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 IV infusion Q1W.

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

Participants received dalotuzumab 15 mg/kg IV infusion Q1W.

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

Participants received dalotuzumab 20 mg/kg IV infusion Q1W or 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)3
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)3
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)7
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)11
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)10
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)15
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)0

Reported measurements

Baseline
Values in H-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)186.735.1Not reportedNot reportedNot reported
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)203.355.1Not reportedNot reportedNot reported
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)218.657.9Not reportedNot reportedNot reported
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)171.840.2Not reportedNot reportedNot reported
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)182.033.9Not reportedNot reportedNot reported
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)146.376.9Not reportedNot reportedNot reported
Change from Baseline
Values in H-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)-1.742.5Not reportedNot reportedNot reported
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)-11.748.6Not reportedNot reportedNot reported
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)-20.068.6Not reportedNot reportedNot reported
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)-2.742.2Not reportedNot reportedNot reported
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)-39.036.3Not reportedNot reportedNot reported
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)-27.054.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.1
        value
        186.7
      2. group Id
        OG001
        spread
        55.1
        value
        203.3
      3. group Id
        OG002
        spread
        57.9
        value
        218.6
      4. group Id
        OG003
        spread
        40.2
        value
        171.8
      5. group Id
        OG004
        spread
        33.9
        value
        182.0
      6. group Id
        OG005
        spread
        76.9
        value
        146.3
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.5
        value
        -1.7
      2. group Id
        OG001
        spread
        48.6
        value
        -11.7
      3. group Id
        OG002
        spread
        68.6
        value
        -20.0
      4. group Id
        OG003
        spread
        42.2
        value
        -2.7
      5. group Id
        OG004
        spread
        36.3
        value
        -39.0
      6. group Id
        OG005
        spread
        54.1
        value
        -27.0
    title
    Change from Baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      11
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      15
    7. group Id
      OG006
      value
      0
    units
    Participants
description
IGF-1R expression was measured in pre- and post-dose skin biopsy samples using an immunohistochemistry (IHC) assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.
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 IV infusion Q1W.
    id
    OG003
    title
    Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
  5. description
    Participants received dalotuzumab 15 mg/kg IV infusion Q1W.
    id
    OG004
    title
    Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
  6. description
    Participants received dalotuzumab 20 mg/kg IV infusion Q1W or Q2W.
    id
    OG005
    title
    Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
  7. description
    Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
    id
    OG006
    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 skin IGF-1R pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 30 mg/kg Q3W treatment group.
reporting Status
POSTED
time Frame
Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)
title
Change From Baseline in Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Expression Level H-score in Skin Samples
type
SECONDARY
unit Of Measure
H-score

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

Preserved source evidence · Not medical advice