Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03989115 · OUTCOME

Accumulation Ratio

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
ratio
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

AUC ratio (C1D15 versus C1D1) 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

Source class 1
Values in ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)1.3656Not reportedNot reportedNot reported
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)1.2224Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)1.2416Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)1.2028Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)1.1941Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D21.2041Not reportedNot reportedNot reported
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)1.1220Not reportedNot reportedNot reported
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)0.84141Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        56
        value
        1.36
      2. group Id
        OG001
        spread
        24
        value
        1.22
      3. group Id
        OG002
        spread
        16
        value
        1.24
      4. group Id
        OG003
        spread
        28
        value
        1.20
      5. group Id
        OG004
        spread
        41
        value
        1.19
      6. group Id
        OG005
        spread
        41
        value
        1.20
      7. group Id
        OG006
        spread
        20
        value
        1.12
      8. group Id
        OG007
        spread
        41
        value
        0.841
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
AUC ratio (C1D15 versus C1D1) 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
Accumulation Ratio
type
SECONDARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice