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NCT03989115 · OUTCOME

t1/2

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
MEDIAN
Unit
h
Interval / dispersion
Full Range
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

Elimination half-life 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 h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)15.7Not reported12.320.2Not reported
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)16.1Not reported15.220.9Not reported
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)15.1Not reported11.720.6Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)16.2Not reported15.135.7Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)17.0Not reported10.826.2Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D216.9Not reported14.920.1Not reported
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)20.1Not reported14.026.2Not reported
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)16.6Not reported16.616.6Not reported
C1D15
Values in h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)20.8Not reported15.031.2Not reported
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)24.5Not reported19.829.2Not reported
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)15.7Not reported14.917.3Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)22.2Not reported16.591.7Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)14.4Not reported5.1818.2Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D218.4Not reported11.324.8Not reported
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)24.6Not reported15.225.2Not reported
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)NANot reportedNANAInsufficient timepoints to calculate this data.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.3
        upper Limit
        20.2
        value
        15.7
      2. group Id
        OG001
        lower Limit
        15.2
        upper Limit
        20.9
        value
        16.1
      3. group Id
        OG002
        lower Limit
        11.7
        upper Limit
        20.6
        value
        15.1
      4. group Id
        OG003
        lower Limit
        15.1
        upper Limit
        35.7
        value
        16.2
      5. group Id
        OG004
        lower Limit
        10.8
        upper Limit
        26.2
        value
        17.0
      6. group Id
        OG005
        lower Limit
        14.9
        upper Limit
        20.1
        value
        16.9
      7. group Id
        OG006
        lower Limit
        14.0
        upper Limit
        26.2
        value
        20.1
      8. group Id
        OG007
        lower Limit
        16.6
        upper Limit
        16.6
        value
        16.6
    title
    C1D1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.0
        upper Limit
        31.2
        value
        20.8
      2. group Id
        OG001
        lower Limit
        19.8
        upper Limit
        29.2
        value
        24.5
      3. group Id
        OG002
        lower Limit
        14.9
        upper Limit
        17.3
        value
        15.7
      4. group Id
        OG003
        lower Limit
        16.5
        upper Limit
        91.7
        value
        22.2
      5. group Id
        OG004
        lower Limit
        5.18
        upper Limit
        18.2
        value
        14.4
      6. group Id
        OG005
        lower Limit
        11.3
        upper Limit
        24.8
        value
        18.4
      7. group Id
        OG006
        lower Limit
        15.2
        upper Limit
        25.2
        value
        24.6
      8. comment
        Insufficient timepoints to calculate this data.
        group Id
        OG007
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    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
Elimination half-life of RMC-4630 and cobimetinib or RMC-4630 and osimertinib
dispersion Type
Full Range
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
MEDIAN
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
t1/2
type
SECONDARY
unit Of Measure
h

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

Preserved source evidence · Not medical advice