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NCT01536145 · OUTCOME

Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871

CP-751,871 Treatment For Patients With Multiple Myeloma · Source last updated 2013-03-15

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

Measure
MEAN
Unit
milligram•hour/liter (mg•hr/L)
Interval / dispersion
Standard Deviation
Time frame
Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose

Analysis population: All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest.

Groups in this outcome

CP-751,871 0.1 mg/kg

CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)

CP-751,871 0.2 mg/kg

CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)

CP-751,871 0.4 mg/kg

CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)

CP-751,871 0.8 mg/kg

CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)

CP-751,871 1.5 mg/kg

CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)

CP-751,871 3 mg/kg

CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)

CP-751,871 6 mg/kg

CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)

CP-751,871 10 mg/kg

CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

CP-751,871 20 mg/kg

CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

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

Analysis denominator · Participants

GroupSource count
CP-751,871 0.1 mg/kg2
CP-751,871 0.2 mg/kg3
CP-751,871 0.4 mg/kg4
CP-751,871 0.8 mg/kg3
CP-751,871 1.5 mg/kg3
CP-751,871 3 mg/kg4
CP-751,871 6 mg/kg3
CP-751,871 10 mg/kg7
CP-751,871 20 mg/kg6

Reported measurements

Source class 1
Values in milligram•hour/liter (mg•hr/L) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CP-751,871 0.1 mg/kg101NANot reportedNot reportedNumber of participants analyzed was less than 3, thus standard deviation was not calculated.
CP-751,871 0.2 mg/kg20229.2Not reportedNot reportedNot reported
CP-751,871 0.4 mg/kg1016583Not reportedNot reportedNot reported
CP-751,871 0.8 mg/kg20791413Not reportedNot reportedNot reported
CP-751,871 1.5 mg/kg83804533Not reportedNot reportedNot reported
CP-751,871 3 mg/kg154366406Not reportedNot reportedNot reported
CP-751,871 6 mg/kg261442672Not reportedNot reportedNot reported
CP-751,871 10 mg/kg3870015019Not reportedNot reportedNot reported
CP-751,871 20 mg/kg9556525891Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Number of participants analyzed was less than 3, thus standard deviation was not calculated.
        group Id
        OG000
        spread
        NA
        value
        101
      2. group Id
        OG001
        spread
        29.2
        value
        202
      3. group Id
        OG002
        spread
        583
        value
        1016
      4. group Id
        OG003
        spread
        1413
        value
        2079
      5. group Id
        OG004
        spread
        4533
        value
        8380
      6. group Id
        OG005
        spread
        6406
        value
        15436
      7. group Id
        OG006
        spread
        2672
        value
        26144
      8. group Id
        OG007
        spread
        15019
        value
        38700
      9. group Id
        OG008
        spread
        25891
        value
        95565
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      7
    9. group Id
      OG008
      value
      6
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
    id
    OG000
    title
    CP-751,871 0.1 mg/kg
  2. description
    CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
    id
    OG001
    title
    CP-751,871 0.2 mg/kg
  3. description
    CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
    id
    OG002
    title
    CP-751,871 0.4 mg/kg
  4. description
    CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
    id
    OG003
    title
    CP-751,871 0.8 mg/kg
  5. description
    CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
    id
    OG004
    title
    CP-751,871 1.5 mg/kg
  6. description
    CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
    id
    OG005
    title
    CP-751,871 3 mg/kg
  7. description
    CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
    id
    OG006
    title
    CP-751,871 6 mg/kg
  8. description
    CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
    id
    OG007
    title
    CP-751,871 10 mg/kg
  9. description
    CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
    id
    OG008
    title
    CP-751,871 20 mg/kg
param Type
MEAN
population Description
All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest.
reporting Status
POSTED
time Frame
Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
title
Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871
type
SECONDARY
unit Of Measure
milligram•hour/liter (mg•hr/L)

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Preserved source evidence · Not medical advice