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NCT03989115 · OUTCOME

Cmax

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
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

Peak plasma concentration 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 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)21445Not reportedNot reportedNot reported
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)24838Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)46942Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)43061Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)35452Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D244927Not reportedNot reportedNot reported
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)24257Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)44925Not reportedNot reportedNot reported
C1D15
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)20790Not reportedNot reportedNot reported
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)26664Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)46537Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)50471Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)39556Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D246920Not reportedNot reportedNot reported
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)28638Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)4083Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        45
        value
        214
      2. group Id
        OG001
        spread
        38
        value
        248
      3. group Id
        OG002
        spread
        42
        value
        469
      4. group Id
        OG003
        spread
        61
        value
        430
      5. group Id
        OG004
        spread
        52
        value
        354
      6. group Id
        OG005
        spread
        27
        value
        449
      7. group Id
        OG006
        spread
        57
        value
        242
      8. group Id
        OG007
        spread
        25
        value
        449
    title
    C1D1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        90
        value
        207
      2. group Id
        OG001
        spread
        64
        value
        266
      3. group Id
        OG002
        spread
        37
        value
        465
      4. group Id
        OG003
        spread
        71
        value
        504
      5. group Id
        OG004
        spread
        56
        value
        395
      6. group Id
        OG005
        spread
        20
        value
        469
      7. group Id
        OG006
        spread
        38
        value
        286
      8. group Id
        OG007
        spread
        3
        value
        408
    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
Peak plasma concentration 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
Cmax
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice