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NCT01667419 · OUTCOME

Plasma Concentration of Vemurafenib

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma · Source last updated 2019-07-23

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

Measure
MEAN
Unit
nanograms per milliliter (ng/mL)
Interval / dispersion
Standard Deviation
Time frame
Pre-morning dose (0 hour [hr]) and 1 to 4 hrs post-dose on Days 1, 8, 15, and 22 of Cycle 1; pre-morning dose (0 hr) on Days 1 and 15 of Cycle 2; pre-morning dose (0 hr) on Day 1 of Cycles 3-13; at end of treatment (up to 13 months)

Analysis population: The pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of vemurafenib and had provided valid PK assessments.

Groups in this outcome

Cohort 1 Vemurafenib

Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks

Cohort 2 Vemurafenib

Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 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
Cohort 1 Vemurafenib149
Cohort 2 Vemurafenib92

Reported measurements

Cycle 1 Day 1 (nominal Day 1)

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib122
Cohort 2 Vemurafenib77
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib28802770Not reportedNot reportedNot reported
Cohort 2 Vemurafenib30503010Not reportedNot reportedNot reported
Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib79
Cohort 2 Vemurafenib52
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4990019800Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4340013600Not reportedNot reportedNot reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib55
Cohort 2 Vemurafenib43
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4530023000Not reportedNot reportedNot reported
Cohort 2 Vemurafenib5020020500Not reportedNot reportedNot reported
Cycle 1 Day 22

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib49
Cohort 2 Vemurafenib45
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4400022400Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4880023700Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib107
Cohort 2 Vemurafenib69
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4020024100Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4380019400Not reportedNot reportedNot reported
Cycle 2 Day 15

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib102
Cohort 2 Vemurafenib68
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4240021700Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4420021200Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib100
Cohort 2 Vemurafenib69
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4670021500Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4370022000Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib98
Cohort 2 Vemurafenib68
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4480019300Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4740020100Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib92
Cohort 2 Vemurafenib61
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4310018800Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4370019400Not reportedNot reportedNot reported
Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib82
Cohort 2 Vemurafenib62
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4600018900Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4200022000Not reportedNot reportedNot reported
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib86
Cohort 2 Vemurafenib57
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4280020500Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4520020500Not reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib81
Cohort 2 Vemurafenib55
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4360019900Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4260018900Not reportedNot reportedNot reported
Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib77
Cohort 2 Vemurafenib51
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4290018400Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4300017700Not reportedNot reportedNot reported
Cycle 10 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib38
Cohort 2 Vemurafenib29
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4100019000Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4390018500Not reportedNot reportedNot reported
Cycle 11 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib35
Cohort 2 Vemurafenib35
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4590015300Not reportedNot reportedNot reported
Cohort 2 Vemurafenib3970017600Not reportedNot reportedNot reported
Cycle 12 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib34
Cohort 2 Vemurafenib26
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4370015200Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4660019800Not reportedNot reportedNot reported
Cycle 13 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Vemurafenib36
Cohort 2 Vemurafenib26
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1 Vemurafenib4400017200Not reportedNot reportedNot reported
Cohort 2 Vemurafenib4260019900Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2770
        value
        2880
      2. group Id
        OG001
        spread
        3010
        value
        3050
    denoms
    1. counts
      1. group Id
        OG000
        value
        122
      2. group Id
        OG001
        value
        77
      units
      Participants
    title
    Cycle 1 Day 1 (nominal Day 1)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19800
        value
        49900
      2. group Id
        OG001
        spread
        13600
        value
        43400
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        52
      units
      Participants
    title
    Cycle 1 Day 8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        23000
        value
        45300
      2. group Id
        OG001
        spread
        20500
        value
        50200
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      2. group Id
        OG001
        value
        43
      units
      Participants
    title
    Cycle 1 Day 15
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22400
        value
        44000
      2. group Id
        OG001
        spread
        23700
        value
        48800
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        45
      units
      Participants
    title
    Cycle 1 Day 22
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        24100
        value
        40200
      2. group Id
        OG001
        spread
        19400
        value
        43800
    denoms
    1. counts
      1. group Id
        OG000
        value
        107
      2. group Id
        OG001
        value
        69
      units
      Participants
    title
    Cycle 2 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        21700
        value
        42400
      2. group Id
        OG001
        spread
        21200
        value
        44200
    denoms
    1. counts
      1. group Id
        OG000
        value
        102
      2. group Id
        OG001
        value
        68
      units
      Participants
    title
    Cycle 2 Day 15
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        21500
        value
        46700
      2. group Id
        OG001
        spread
        22000
        value
        43700
    denoms
    1. counts
      1. group Id
        OG000
        value
        100
      2. group Id
        OG001
        value
        69
      units
      Participants
    title
    Cycle 3 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        19300
        value
        44800
      2. group Id
        OG001
        spread
        20100
        value
        47400
    denoms
    1. counts
      1. group Id
        OG000
        value
        98
      2. group Id
        OG001
        value
        68
      units
      Participants
    title
    Cycle 4 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        18800
        value
        43100
      2. group Id
        OG001
        spread
        19400
        value
        43700
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      2. group Id
        OG001
        value
        61
      units
      Participants
    title
    Cycle 5 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        18900
        value
        46000
      2. group Id
        OG001
        spread
        22000
        value
        42000
    denoms
    1. counts
      1. group Id
        OG000
        value
        82
      2. group Id
        OG001
        value
        62
      units
      Participants
    title
    Cycle 6 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        20500
        value
        42800
      2. group Id
        OG001
        spread
        20500
        value
        45200
    denoms
    1. counts
      1. group Id
        OG000
        value
        86
      2. group Id
        OG001
        value
        57
      units
      Participants
    title
    Cycle 7 Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        19900
        value
        43600
      2. group Id
        OG001
        spread
        18900
        value
        42600
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      2. group Id
        OG001
        value
        55
      units
      Participants
    title
    Cycle 8 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      149
    2. group Id
      OG001
      value
      92
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
    id
    OG000
    title
    Cohort 1 Vemurafenib
  2. description
    Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
    id
    OG001
    title
    Cohort 2 Vemurafenib
param Type
MEAN
population Description
The pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of vemurafenib and had provided valid PK assessments.
reporting Status
POSTED
time Frame
Pre-morning dose (0 hour [hr]) and 1 to 4 hrs post-dose on Days 1, 8, 15, and 22 of Cycle 1; pre-morning dose (0 hr) on Days 1 and 15 of Cycle 2; pre-morning dose (0 hr) on Day 1 of Cycles 3-13; at end of treatment (up to 13 months)
title
Plasma Concentration of Vemurafenib
type
SECONDARY
unit Of Measure
nanograms per milliliter (ng/mL)

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

Preserved source evidence · Not medical advice