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NCT01006980 · OUTCOME

Pre and Post-dose Plasma Vemurafenib Concentration by Study Day

A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3) · Source last updated 2016-09-28

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

Measure
MEAN
Unit
μg/mL
Interval / dispersion
Standard Deviation
Time frame
Plasma samples were collected before the morning dose (troughs) and 2-4 hours after the morning dose at the beginning of each cycle (Days 1, 22, 43, 64, 106, 148 and 190).

What was measured

The pharmacokinetics of vemurafenib were assessed at the beginning of each 21-day cycle using pre-dose and 2-4 hours post-dose sampling.

Analysis population: The pharmacokinetic (PK) analysis population included all participants who received vemurafenib and provided valid PK assessments. The PK population at specific time points varied depending on the availability of confirmed dosing and PK assessment times. "n" indicates the number of participants with available PK data at each time point.

Groups in this outcome

Vemurafenib

Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).

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

Analysis denominator · Participants

GroupSource count
Vemurafenib260

Reported measurements

Pre-Dose Day 1 (n = 260)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib00Not reportedNot reportedNot reported
Post-Dose Day 1 (n = 255)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib4.34.35Not reportedNot reportedNot reported
Pre-Dose Day 22 (n = 204)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib53.026.66Not reportedNot reportedNot reported
Post-Dose Day 22 (n = 221)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib54.025.67Not reportedNot reportedNot reported
Pre-Dose Day 43 (n = 166)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib54.424.13Not reportedNot reportedNot reported
Post-Dose Day 43 (n = 170)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib54.423.28Not reportedNot reportedNot reported
Pre-Dose Day 64 (n = 141)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib57.423.79Not reportedNot reportedNot reported
Post-Dose Day 64 (n = 138)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib57.722.29Not reportedNot reportedNot reported
Pre-Dose Day 106 (n = 77)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib55.017.62Not reportedNot reportedNot reported
Post-Dose Day 106 (n = 75)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib56.320.36Not reportedNot reportedNot reported
Pre-Dose Day 148 (n = 38)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib51.824.13Not reportedNot reportedNot reported
Post-Dose Day 148 (n = 39)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib53.321.55Not reportedNot reportedNot reported
Pre-Dose Day 190 (n = 9)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib53.612.6Not reportedNot reportedNot reported
Post-Dose Day 190 (n = 9)
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Vemurafenib50.520.16Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0
        value
        0
    title
    Pre-Dose Day 1 (n = 260)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.35
        value
        4.3
    title
    Post-Dose Day 1 (n = 255)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.66
        value
        53.0
    title
    Pre-Dose Day 22 (n = 204)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.67
        value
        54.0
    title
    Post-Dose Day 22 (n = 221)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.13
        value
        54.4
    title
    Pre-Dose Day 43 (n = 166)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.28
        value
        54.4
    title
    Post-Dose Day 43 (n = 170)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.79
        value
        57.4
    title
    Pre-Dose Day 64 (n = 141)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.29
        value
        57.7
    title
    Post-Dose Day 64 (n = 138)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.62
        value
        55.0
    title
    Pre-Dose Day 106 (n = 77)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.36
        value
        56.3
    title
    Post-Dose Day 106 (n = 75)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.13
        value
        51.8
    title
    Pre-Dose Day 148 (n = 38)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.55
        value
        53.3
    title
    Post-Dose Day 148 (n = 39)
denoms
  1. counts
    1. group Id
      OG000
      value
      260
    units
    Participants
description
The pharmacokinetics of vemurafenib were assessed at the beginning of each 21-day cycle using pre-dose and 2-4 hours post-dose sampling.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
    id
    OG000
    title
    Vemurafenib
param Type
MEAN
population Description
The pharmacokinetic (PK) analysis population included all participants who received vemurafenib and provided valid PK assessments. The PK population at specific time points varied depending on the availability of confirmed dosing and PK assessment times. "n" indicates the number of participants with available PK data at each time point.
reporting Status
POSTED
time Frame
Plasma samples were collected before the morning dose (troughs) and 2-4 hours after the morning dose at the beginning of each cycle (Days 1, 22, 43, 64, 106, 148 and 190).
title
Pre and Post-dose Plasma Vemurafenib Concentration by Study Day
type
SECONDARY
unit Of Measure
μg/mL

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

Preserved source evidence · Not medical advice