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NCT01327053 · OUTCOME

Plasma Concentration of Sonidegib (LDE225)

A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma · Source last updated 2019-08-28

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Weeks 1, 3, 5, 9, 13, 17, 21, 33, 45, 57, 69

What was measured

Blood PK samples were collected either by direct venipuncture or an indwelling cannula inserted in a forearm vein for the determination of trough (Cmin) plasma concentrations of sonidegib and its main circulating metabolite, LGE899, from all patients who enrolled in the study. Blood was collected in Weeks 1, 3, 5, 9 (pre-dose), and subsequently pre-dose every 4 weeks up to Week 21, and every 12 weeks thereafter up to week 69.

Analysis population: The PK analysis set (PAS) consisted of all patients with at least one evaluable plasma concentration.

Groups in this outcome

LDE225 200 mg qd

Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

LDE225 800 mg qd

Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

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

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd73
LDE225 800 mg qd139

Reported measurements

Week 1 (0 h (pre-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd73
LDE225 800 mg qd139
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qdNANANot reportedNot reportedN/A = Week1 pre-dose concentrations were below limit of quantitation
LDE225 800 mg qdNANANot reportedNot reportedN/A = Week1 pre-dose concentrations were below limit of quantitation
Week 3 (0 h (pre-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd65
LDE225 800 mg qd128
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd207.7678.29Not reportedNot reportedNot reported
LDE225 800 mg qd586.7697.13Not reportedNot reportedNot reported
Week 5 (0 h (pre-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd70
LDE225 800 mg qd120
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd372.2668.89Not reportedNot reportedNot reported
LDE225 800 mg qd1012.6370.42Not reportedNot reportedNot reported
Week 9 (0 h (pre-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd68
LDE225 800 mg qd101
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd559.2967.30Not reportedNot reportedNot reported
LDE225 800 mg qd1353.0663.43Not reportedNot reportedNot reported
Week 13 (0 h (pre-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd63
LDE225 800 mg qd85
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd714.0160.79Not reportedNot reportedNot reported
LDE225 800 mg qd1443.8461.57Not reportedNot reportedNot reported
Week 17 (0 h (pre-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd66
LDE225 800 mg qd81
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd688.9364.43Not reportedNot reportedNot reported
LDE225 800 mg qd1574.2159.88Not reportedNot reportedNot reported
Week 17 (1 h (post-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd35
LDE225 800 mg qd35
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd841.7852.57Not reportedNot reportedNot reported
LDE225 800 mg qd1803.7439.47Not reportedNot reportedNot reported
Week 17 (2 h (post-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd37
LDE225 800 mg qd32
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd939.5650.79Not reportedNot reportedNot reported
LDE225 800 mg qd1922.3834.90Not reportedNot reportedNot reported
Week 17 (4 h (post-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd36
LDE225 800 mg qd33
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd842.3162.22Not reportedNot reportedNot reported
LDE225 800 mg qd1750.7053.32Not reportedNot reportedNot reported
Week 17 (6 h (post-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd33
LDE225 800 mg qd32
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd759.8863.43Not reportedNot reportedNot reported
LDE225 800 mg qd1673.9541.53Not reportedNot reportedNot reported
Week 21 (0 h (pre-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd58
LDE225 800 mg qd67
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd707.4963.58Not reportedNot reportedNot reported
LDE225 800 mg qd1547.4163.92Not reportedNot reportedNot reported
Week 33 (0 h (pre-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd49
LDE225 800 mg qd49
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd702.6793.11Not reportedNot reportedNot reported
LDE225 800 mg qd1477.6074.80Not reportedNot reportedNot reported
Week 45 (0 h (pre-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd33
LDE225 800 mg qd35
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd697.9276.02Not reportedNot reportedNot reported
LDE225 800 mg qd1368.8779.60Not reportedNot reportedNot reported
Week 57 (0 h (pre-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd22
LDE225 800 mg qd26
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd559.17117.27Not reportedNot reportedNot reported
LDE225 800 mg qd1257.4278.96Not reportedNot reportedNot reported
Wek 69 (0 h (pre-dose))

Analysis denominator · Participants

GroupSource count
LDE225 200 mg qd21
LDE225 800 mg qd23
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LDE225 200 mg qd530.91154.33Not reportedNot reportedNot reported
LDE225 800 mg qd1355.9189.03Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        N/A = Week1 pre-dose concentrations were below limit of quantitation
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        N/A = Week1 pre-dose concentrations were below limit of quantitation
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        139
      units
      Participants
    title
    Week 1 (0 h (pre-dose))
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        78.29
        value
        207.76
      2. group Id
        OG001
        spread
        97.13
        value
        586.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        128
      units
      Participants
    title
    Week 3 (0 h (pre-dose))
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        68.89
        value
        372.26
      2. group Id
        OG001
        spread
        70.42
        value
        1012.63
    denoms
    1. counts
      1. group Id
        OG000
        value
        70
      2. group Id
        OG001
        value
        120
      units
      Participants
    title
    Week 5 (0 h (pre-dose))
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.30
        value
        559.29
      2. group Id
        OG001
        spread
        63.43
        value
        1353.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      2. group Id
        OG001
        value
        101
      units
      Participants
    title
    Week 9 (0 h (pre-dose))
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.79
        value
        714.01
      2. group Id
        OG001
        spread
        61.57
        value
        1443.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        85
      units
      Participants
    title
    Week 13 (0 h (pre-dose))
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        64.43
        value
        688.93
      2. group Id
        OG001
        spread
        59.88
        value
        1574.21
    denoms
    1. counts
      1. group Id
        OG000
        value
        66
      2. group Id
        OG001
        value
        81
      units
      Participants
    title
    Week 17 (0 h (pre-dose))
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.57
        value
        841.78
      2. group Id
        OG001
        spread
        39.47
        value
        1803.74
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    Week 17 (1 h (post-dose))
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.79
        value
        939.56
      2. group Id
        OG001
        spread
        34.90
        value
        1922.38
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        32
      units
      Participants
    title
    Week 17 (2 h (post-dose))
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        62.22
        value
        842.31
      2. group Id
        OG001
        spread
        53.32
        value
        1750.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        33
      units
      Participants
    title
    Week 17 (4 h (post-dose))
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        63.43
        value
        759.88
      2. group Id
        OG001
        spread
        41.53
        value
        1673.95
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        32
      units
      Participants
    title
    Week 17 (6 h (post-dose))
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        63.58
        value
        707.49
      2. group Id
        OG001
        spread
        63.92
        value
        1547.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        67
      units
      Participants
    title
    Week 21 (0 h (pre-dose))
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        93.11
        value
        702.67
      2. group Id
        OG001
        spread
        74.80
        value
        1477.60
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        49
      units
      Participants
    title
    Week 33 (0 h (pre-dose))
denoms
  1. counts
    1. group Id
      OG000
      value
      73
    2. group Id
      OG001
      value
      139
    units
    Participants
description
Blood PK samples were collected either by direct venipuncture or an indwelling cannula inserted in a forearm vein for the determination of trough (Cmin) plasma concentrations of sonidegib and its main circulating metabolite, LGE899, from all patients who enrolled in the study. Blood was collected in Weeks 1, 3, 5, 9 (pre-dose), and subsequently pre-dose every 4 weeks up to Week 21, and every 12 weeks thereafter up to week 69.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
    id
    OG000
    title
    LDE225 200 mg qd
  2. description
    Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
    id
    OG001
    title
    LDE225 800 mg qd
param Type
GEOMETRIC_MEAN
population Description
The PK analysis set (PAS) consisted of all patients with at least one evaluable plasma concentration.
reporting Status
POSTED
time Frame
Weeks 1, 3, 5, 9, 13, 17, 21, 33, 45, 57, 69
title
Plasma Concentration of Sonidegib (LDE225)
type
SECONDARY
unit Of Measure
ng/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice