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NCT01883362 · OUTCOME

Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels

Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML · Source last updated 2021-03-17

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

Measure
MEAN
Unit
ng/ml
Interval / dispersion
Standard Deviation
Time frame
Pre-dose on days 1 and 15 of Cycle 1, on day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

What was measured

Pre-dose levels (Cmin) will be directly determined from raw plasma concentration-time data. Values below the lower limit of quantification (LLOQ) will be treated as zero in any calculations of summary statistics.

Analysis population: number of samples available differed across time points

Groups in this outcome

PKC412

Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).

Metabolite CGP52421

Metabolite of PKC412 (CGP52421)

Metabolite CGP62221

Metabolite of PKC412 (CGP62221)

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

Analysis denominator · Participants

GroupSource count
PKC41229
Metabolite CGP5242129
Metabolite CGP6222129

Reported measurements

Visit 2,Cycle1,Day 1

Analysis denominator · Participants

GroupSource count
PKC41227
Metabolite CGP5242127
Metabolite CGP6222127
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PKC41217.4676.806Not reportedNot reportedNot reported
Metabolite CGP524210.000.000Not reportedNot reportedNot reported
Metabolite CGP6222116.8961.212Not reportedNot reportedNot reported
Visit 4,Cycle1, Day 15

Analysis denominator · Participants

GroupSource count
PKC41228
Metabolite CGP5242128
Metabolite CGP6222129
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PKC412932.46770.597Not reportedNot reportedNot reported
Metabolite CGP524211572.69684.955Not reportedNot reportedNot reported
Metabolite CGP62221906.57747.836Not reportedNot reportedNot reported
Visit 5,Cycle2,Day 1

Analysis denominator · Participants

GroupSource count
PKC41226
Metabolite CGP5242126
Metabolite CGP6222126
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PKC412769.92485.353Not reportedNot reportedNot reported
Metabolite CGP524211768.77849.580Not reportedNot reportedNot reported
Metabolite CGP62221779.90400.244Not reportedNot reportedNot reported
Visit 6,Cycle3,Day 1

Analysis denominator · Participants

GroupSource count
PKC41220
Metabolite CGP5242120
Metabolite CGP6222120
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PKC412907.20528.017Not reportedNot reportedNot reported
Metabolite CGP524212051.55765.758Not reportedNot reportedNot reported
Metabolite CGP62221929.45311.841Not reportedNot reportedNot reported
Visit 7,Cycle4,Day 1

Analysis denominator · Participants

GroupSource count
PKC41220
Metabolite CGP5242120
Metabolite CGP6222120
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PKC412548.45459.294Not reportedNot reportedNot reported
Metabolite CGP524211707.15810.143Not reportedNot reportedNot reported
Metabolite CGP62221714.00610.925Not reportedNot reportedNot reported
Visit 8,Cycle5,Day 1

Analysis denominator · Participants

GroupSource count
PKC41220
Metabolite CGP5242120
Metabolite CGP6222120
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PKC412525.73255.032Not reportedNot reportedNot reported
Metabolite CGP524211742.85658.905Not reportedNot reportedNot reported
Metabolite CGP62221722.00320.977Not reportedNot reportedNot reported
Visit 9,Cycle6,Day 1

Analysis denominator · Participants

GroupSource count
PKC41221
Metabolite CGP5242121
Metabolite CGP6222121
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PKC412519.10328.032Not reportedNot reportedNot reported
Metabolite CGP524211757.86685.740Not reportedNot reportedNot reported
Metabolite CGP62221763.86408.290Not reportedNot reportedNot reported
Visit 10,Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
PKC41220
Metabolite CGP5242120
Metabolite CGP6222120
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PKC412754.95497.976Not reportedNot reportedNot reported
Metabolite CGP524211717.35720.259Not reportedNot reportedNot reported
Metabolite CGP62221780.65424.200Not reportedNot reportedNot reported
Visit 11,Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
PKC41219
Metabolite CGP5242119
Metabolite CGP6222119
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PKC412537.95229.529Not reportedNot reportedNot reported
Metabolite CGP524211787.21733.162Not reportedNot reportedNot reported
Metabolite CGP62221774.84326.583Not reportedNot reportedNot reported
Visit 12,Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
PKC41217
Metabolite CGP5242117
Metabolite CGP6222117
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PKC412571.76311.764Not reportedNot reportedNot reported
Metabolite CGP524211889.76678.435Not reportedNot reportedNot reported
Metabolite CGP62221850.47328.411Not reportedNot reportedNot reported
Visit 13,Cycle 10 Day 1

Analysis denominator · Participants

GroupSource count
PKC41218
Metabolite CGP5242118
Metabolite CGP6222118
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PKC412643.07452.268Not reportedNot reportedNot reported
Metabolite CGP524211836.50632.894Not reportedNot reportedNot reported
Metabolite CGP62221851.38347.311Not reportedNot reportedNot reported
Visit 14,Cycle 11 Day 1

Analysis denominator · Participants

GroupSource count
PKC41218
Metabolite CGP5242118
Metabolite CGP6222118
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PKC412718.22538.208Not reportedNot reportedNot reported
Metabolite CGP524211857.33868.406Not reportedNot reportedNot reported
Metabolite CGP62221983.94801.361Not reportedNot reportedNot reported
Visit 15,Cycle 12 Day 1

Analysis denominator · Participants

GroupSource count
PKC41217
Metabolite CGP5242117
Metabolite CGP6222117
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PKC412564.69410.156Not reportedNot reportedNot reported
Metabolite CGP524211706.29643.326Not reportedNot reportedNot reported
Metabolite CGP62221763.60387.685Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        76.806
        value
        17.46
      2. group Id
        OG001
        spread
        0.000
        value
        0.00
      3. group Id
        OG002
        spread
        61.212
        value
        16.89
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        27
      3. group Id
        OG002
        value
        27
      units
      Participants
    title
    Visit 2,Cycle1,Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        770.597
        value
        932.46
      2. group Id
        OG001
        spread
        684.955
        value
        1572.69
      3. group Id
        OG002
        spread
        747.836
        value
        906.57
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        28
      3. group Id
        OG002
        value
        29
      units
      Participants
    title
    Visit 4,Cycle1, Day 15
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        485.353
        value
        769.92
      2. group Id
        OG001
        spread
        849.580
        value
        1768.77
      3. group Id
        OG002
        spread
        400.244
        value
        779.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        26
      3. group Id
        OG002
        value
        26
      units
      Participants
    title
    Visit 5,Cycle2,Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        528.017
        value
        907.20
      2. group Id
        OG001
        spread
        765.758
        value
        2051.55
      3. group Id
        OG002
        spread
        311.841
        value
        929.45
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        20
      units
      Participants
    title
    Visit 6,Cycle3,Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        459.294
        value
        548.45
      2. group Id
        OG001
        spread
        810.143
        value
        1707.15
      3. group Id
        OG002
        spread
        610.925
        value
        714.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        20
      units
      Participants
    title
    Visit 7,Cycle4,Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        255.032
        value
        525.73
      2. group Id
        OG001
        spread
        658.905
        value
        1742.85
      3. group Id
        OG002
        spread
        320.977
        value
        722.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        20
      units
      Participants
    title
    Visit 8,Cycle5,Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        328.032
        value
        519.10
      2. group Id
        OG001
        spread
        685.740
        value
        1757.86
      3. group Id
        OG002
        spread
        408.290
        value
        763.86
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        21
      units
      Participants
    title
    Visit 9,Cycle6,Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        497.976
        value
        754.95
      2. group Id
        OG001
        spread
        720.259
        value
        1717.35
      3. group Id
        OG002
        spread
        424.200
        value
        780.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        20
      units
      Participants
    title
    Visit 10,Cycle 7 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        229.529
        value
        537.95
      2. group Id
        OG001
        spread
        733.162
        value
        1787.21
      3. group Id
        OG002
        spread
        326.583
        value
        774.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        19
      units
      Participants
    title
    Visit 11,Cycle 8 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        311.764
        value
        571.76
      2. group Id
        OG001
        spread
        678.435
        value
        1889.76
      3. group Id
        OG002
        spread
        328.411
        value
        850.47
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        17
      units
      Participants
    title
    Visit 12,Cycle 9 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        452.268
        value
        643.07
      2. group Id
        OG001
        spread
        632.894
        value
        1836.50
      3. group Id
        OG002
        spread
        347.311
        value
        851.38
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        18
      units
      Participants
    title
    Visit 13,Cycle 10 Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        538.208
        value
        718.22
      2. group Id
        OG001
        spread
        868.406
        value
        1857.33
      3. group Id
        OG002
        spread
        801.361
        value
        983.94
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        18
      units
      Participants
    title
    Visit 14,Cycle 11 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      29
    3. group Id
      OG002
      value
      29
    units
    Participants
description
Pre-dose levels (Cmin) will be directly determined from raw plasma concentration-time data. Values below the lower limit of quantification (LLOQ) will be treated as zero in any calculations of summary statistics.
dispersion Type
Standard Deviation
groups
  1. description
    Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
    id
    OG000
    title
    PKC412
  2. description
    Metabolite of PKC412 (CGP52421)
    id
    OG001
    title
    Metabolite CGP52421
  3. description
    Metabolite of PKC412 (CGP62221)
    id
    OG002
    title
    Metabolite CGP62221
param Type
MEAN
population Description
number of samples available differed across time points
reporting Status
POSTED
time Frame
Pre-dose on days 1 and 15 of Cycle 1, on day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
title
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
type
SECONDARY
unit Of Measure
ng/ml

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Preserved source evidence · Not medical advice