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NCT03989115 · OUTCOME

Area Under the Curve (AUC)

Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC · Source last updated 2023-06-26

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL x h
Interval / dispersion
Geometric Coefficient of Variation
Time frame
0, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle1 Day 1 and Cycle 1 Day 15

What was measured

Area under the plasma concentration time curve of RMC-4630 and cobimetinib or RMC-4630 and osimertinib

Groups in this outcome

Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)

Participants who received intermittent dose of RMC-4630 80 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20 mg QD 21days on and 7 days off of a 28-day cycle.

Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)

Participants who received intermittent dose of RMC-4630 80mg on D1 and D4 of a 28-day cycle and Cobimetinib 40mg QD 21days on and 7 days off of a 28-day cycle.

Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.

Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.

Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 40mg D1 and D2 of a 28-day cycle.

Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 60mg D1 and D2 of a 28-day cycle.

Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)

Participants who received intermittent dose of RMC-4630 100 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.

Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)8
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)6
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)12
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)7
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)65
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D27
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)4
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)4

Reported measurements

C1D1
Values in ng/mL x h · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)257034Not reportedNot reportedNot reported
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)258030Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)551038Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)461039Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)470038Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2472026Not reportedNot reportedNot reported
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)336028Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)592015Not reportedNot reportedNot reported
C1D15
Values in ng/mL x h · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)322091Not reportedNot reportedNot reported
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)336044Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)637037Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)558045Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)546045Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2560018Not reportedNot reportedNot reported
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)423035Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)550026Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        34
        value
        2570
      2. group Id
        OG001
        spread
        30
        value
        2580
      3. group Id
        OG002
        spread
        38
        value
        5510
      4. group Id
        OG003
        spread
        39
        value
        4610
      5. group Id
        OG004
        spread
        38
        value
        4700
      6. group Id
        OG005
        spread
        26
        value
        4720
      7. group Id
        OG006
        spread
        28
        value
        3360
      8. group Id
        OG007
        spread
        15
        value
        5920
    title
    C1D1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        91
        value
        3220
      2. group Id
        OG001
        spread
        44
        value
        3360
      3. group Id
        OG002
        spread
        37
        value
        6370
      4. group Id
        OG003
        spread
        45
        value
        5580
      5. group Id
        OG004
        spread
        45
        value
        5460
      6. group Id
        OG005
        spread
        18
        value
        5600
      7. group Id
        OG006
        spread
        35
        value
        4230
      8. group Id
        OG007
        spread
        26
        value
        5500
    title
    C1D15
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      65
    6. group Id
      OG005
      value
      7
    7. group Id
      OG006
      value
      4
    8. group Id
      OG007
      value
      4
    units
    Participants
description
Area under the plasma concentration time curve of RMC-4630 and cobimetinib or RMC-4630 and osimertinib
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants who received intermittent dose of RMC-4630 80 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20 mg QD 21days on and 7 days off of a 28-day cycle.
    id
    OG000
    title
    Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)
  2. description
    Participants who received intermittent dose of RMC-4630 80mg on D1 and D4 of a 28-day cycle and Cobimetinib 40mg QD 21days on and 7 days off of a 28-day cycle.
    id
    OG001
    title
    Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)
  3. description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.
    id
    OG002
    title
    Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)
  4. description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.
    id
    OG003
    title
    Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)
  5. description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 40mg D1 and D2 of a 28-day cycle.
    id
    OG004
    title
    Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)
  6. description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 60mg D1 and D2 of a 28-day cycle.
    id
    OG005
    title
    Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2
  7. description
    Participants who received intermittent dose of RMC-4630 100 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.
    id
    OG006
    title
    Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)
  8. description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.
    id
    OG007
    title
    Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)
param Type
GEOMETRIC_MEAN
reporting Status
POSTED
time Frame
0, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle1 Day 1 and Cycle 1 Day 15
title
Area Under the Curve (AUC)
type
SECONDARY
unit Of Measure
ng/mL x h

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice