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NCT03312530 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) of Cobimetinib

A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma · Source last updated 2023-02-28

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
Pre-dose (within 1 hr), 2, 4, 6 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)

What was measured

Cmax is the maximum observed plasma concentration at steady state.

Analysis population: The PK population included participants from Arms A, B, and C who received at least one dose of study medication and for whom at least one evaluable PK sample was collected.

Groups in this outcome

Safety Run-In: Cobimetinib + Venetoclax

Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.

Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab

Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.

A: Cobimetinib

Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.

B: Cobimetinib + Venetoclax

Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.

C: Cobimetinib + Venetoclax + Atezolizumab

Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Safety Run-In: Cobimetinib + Venetoclax4
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab5
A: Cobimetinib0
B: Cobimetinib + Venetoclax13
C: Cobimetinib + Venetoclax + Atezolizumab12

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Safety Run-In: Cobimetinib + Venetoclax15763.5Not reportedNot reportedNot reported
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab19261.7Not reportedNot reportedNot reported
B: Cobimetinib + Venetoclax14872.6Not reportedNot reportedNot reported
C: Cobimetinib + Venetoclax + Atezolizumab16661.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        63.5
        value
        157
      2. group Id
        OG001
        spread
        61.7
        value
        192
      3. group Id
        OG003
        spread
        72.6
        value
        148
      4. group Id
        OG004
        spread
        61.0
        value
        166
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      13
    5. group Id
      OG004
      value
      12
    units
    Participants
description
Cmax is the maximum observed plasma concentration at steady state.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
    id
    OG000
    title
    Safety Run-In: Cobimetinib + Venetoclax
  2. description
    Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
    id
    OG001
    title
    Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
  3. description
    Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
    id
    OG002
    title
    A: Cobimetinib
  4. description
    Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
    id
    OG003
    title
    B: Cobimetinib + Venetoclax
  5. description
    Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
    id
    OG004
    title
    C: Cobimetinib + Venetoclax + Atezolizumab
param Type
GEOMETRIC_MEAN
population Description
The PK population included participants from Arms A, B, and C who received at least one dose of study medication and for whom at least one evaluable PK sample was collected.
reporting Status
POSTED
time Frame
Pre-dose (within 1 hr), 2, 4, 6 hrs post-dose on Day 15 of Cycle 1 (cycle length: 28 days)
title
Maximum Observed Plasma Concentration (Cmax) of Cobimetinib
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice