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NCT02422615 · OUTCOME

Ribociclib Plasma Concentrations

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. · Source last updated 2023-11-30

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

Measure
GEOMETRIC_MEAN
Unit
nanogram (ng) / miliLiter (mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 and Cycle 2 at Day 15 pre-dose and at 2, 4, and 6 hours post-dose. Cycle=28 days

What was measured

Blood samples were collected to assess the concentration by time point for ribociclib. Participants were classified into the following dose groups at each timepoint: 1) ribociclib 600 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 600 mg immediately prior to the blood collection without a dose change or interruption. 2) ribociclib 400 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 400 mg immediately prior to the blood collection without a dose change or interruption. 3) ribociclib 200 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 200 mg immediately prior to the blood collection without a dose change or interruption.

Analysis population: All participants with at least one evaluable ribociclib concentration. Number analyzed indicated the number of participants with an evaluable ribociclib concentration at the specified time point.

Groups in this outcome

Ribociclib + Fulvestrant

Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.

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

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant253

Reported measurements

Cycle 1 Day 15 predose (ribociclib 600 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant253
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant62767.6Not reportedNot reportedNot reported
Cycle 1 Day 15 predose (ribociclib 400 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant0
Cycle 1 Day 15 predose (ribociclib 200 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant0
Cycle 1 Day 15 2 hours post-dose (ribociclib 600 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant102
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant167052.0Not reportedNot reportedNot reported
Cycle 1 Day 15 2 hours post-dose (ribociclib 400 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant0
Cycle 1 Day 15 2 hours post-dose (ribociclib 200 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant0
Cycle 1 Day 15 4 hours post-dose (ribociclib 600 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant107
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant169046.2Not reportedNot reportedNot reported
Cycle 1 Day 15 4 hours post-dose (ribociclib 400 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant0
Cycle 1 Day 15 4 hours post-dose (ribociclib 200 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant0
Cycle 1 Day 15 6 hours post-dose (ribociclib 600 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant92
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant142050.9Not reportedNot reportedNot reported
Cycle 1 Day 15 6 hours post-dose (ribociclib 400 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant0
Cycle 1 Day 15 6 hours post-dose (ribociclib 200 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant0
Cycle 2 Day 15 predose (ribociclib 600 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant177
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant55380.7Not reportedNot reportedNot reported
Cycle 2 Day 15 predose (ribociclib 400 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant7
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant22081.6Not reportedNot reportedNot reported
Cycle 2 Day 15 predose (ribociclib 200 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant0
Cycle 2 Day 15 2 hours post-dose (ribociclib 600 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant75
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant147080.7Not reportedNot reportedNot reported
Cycle 2 Day 15 2 hours post-dose (ribociclib 400 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant7
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant79485.0Not reportedNot reportedNot reported
Cycle 2 Day 15 2 hours post-dose (ribociclib 200 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant1
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant104Not reportedNot reportedNot reportedNot reported
Cycle 2 Day 15 4 hours post-dose (ribociclib 600 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant79
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant161053.6Not reportedNot reportedNot reported
Cycle 2 Day 15 4 hours post-dose (ribociclib 400 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant7
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant91369.4Not reportedNot reportedNot reported
Cycle 2 Day 15 4 hours post-dose (ribociclib 200 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant1
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant112Not reportedNot reportedNot reportedNot reported
Cycle 2 Day 15 6 hours post-dose (ribociclib 600 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant69
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant128089.6Not reportedNot reportedNot reported
Cycle 2 Day 15 6 hours post-dose (ribociclib 400 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant5
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant71047.4Not reportedNot reportedNot reported
Cycle 2 Day 15 6 hours post-dose (ribociclib 200 mg)

Analysis denominator · Participants

GroupSource count
Ribociclib + Fulvestrant1
Values in nanogram (ng) / miliLiter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ribociclib + Fulvestrant104Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.6
        value
        627
    denoms
    1. counts
      1. group Id
        OG000
        value
        253
      units
      Participants
    title
    Cycle 1 Day 15 predose (ribociclib 600 mg)
  2. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 1 Day 15 predose (ribociclib 400 mg)
  3. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 1 Day 15 predose (ribociclib 200 mg)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.0
        value
        1670
    denoms
    1. counts
      1. group Id
        OG000
        value
        102
      units
      Participants
    title
    Cycle 1 Day 15 2 hours post-dose (ribociclib 600 mg)
  5. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 1 Day 15 2 hours post-dose (ribociclib 400 mg)
  6. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 1 Day 15 2 hours post-dose (ribociclib 200 mg)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.2
        value
        1690
    denoms
    1. counts
      1. group Id
        OG000
        value
        107
      units
      Participants
    title
    Cycle 1 Day 15 4 hours post-dose (ribociclib 600 mg)
  8. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 1 Day 15 4 hours post-dose (ribociclib 400 mg)
  9. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 1 Day 15 4 hours post-dose (ribociclib 200 mg)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.9
        value
        1420
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      units
      Participants
    title
    Cycle 1 Day 15 6 hours post-dose (ribociclib 600 mg)
  11. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 1 Day 15 6 hours post-dose (ribociclib 400 mg)
  12. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 1 Day 15 6 hours post-dose (ribociclib 200 mg)
denoms
  1. counts
    1. group Id
      OG000
      value
      253
    units
    Participants
description
Blood samples were collected to assess the concentration by time point for ribociclib. Participants were classified into the following dose groups at each timepoint: 1) ribociclib 600 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 600 mg immediately prior to the blood collection without a dose change or interruption. 2) ribociclib 400 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 400 mg immediately prior to the blood collection without a dose change or interruption. 3) ribociclib 200 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 200 mg immediately prior to the blood collection without a dose change or interruption.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.
    id
    OG000
    title
    Ribociclib + Fulvestrant
param Type
GEOMETRIC_MEAN
population Description
All participants with at least one evaluable ribociclib concentration. Number analyzed indicated the number of participants with an evaluable ribociclib concentration at the specified time point.
reporting Status
POSTED
time Frame
Cycle 1 and Cycle 2 at Day 15 pre-dose and at 2, 4, and 6 hours post-dose. Cycle=28 days
title
Ribociclib Plasma Concentrations
type
SECONDARY
unit Of Measure
nanogram (ng) / miliLiter (mL)

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Preserved source evidence · Not medical advice