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NCT03989115 · OUTCOME

Tmax

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

Time to achieve 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 h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)2.94Not reported1.004.13Not reported
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)2.00Not reported1.002.03Not reported
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)1.99Not reported0.907.50Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)1.02Not reported0.982.00Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)2.00Not reported0.428.00Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D21.92Not reported0.923.97Not reported
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)2.03Not reported0.987.55Not reported
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)2.95Not reported1.074.10Not reported
C1D15
Values in h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)2.04Not reported1.004.07Not reported
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)2.08Not reported0.974.99Not reported
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)3.04Not reported1.877.77Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)1.08Not reported1.002.12Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)2.00Not reported0.5723.7Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D21.96Not reported0.972.07Not reported
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)1.98Not reported1.882.00Not reported
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)4.07Not reported4.054.08Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        4.13
        value
        2.94
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        2.03
        value
        2.00
      3. group Id
        OG002
        lower Limit
        0.90
        upper Limit
        7.50
        value
        1.99
      4. group Id
        OG003
        lower Limit
        0.98
        upper Limit
        2.00
        value
        1.02
      5. group Id
        OG004
        lower Limit
        0.42
        upper Limit
        8.00
        value
        2.00
      6. group Id
        OG005
        lower Limit
        0.92
        upper Limit
        3.97
        value
        1.92
      7. group Id
        OG006
        lower Limit
        0.98
        upper Limit
        7.55
        value
        2.03
      8. group Id
        OG007
        lower Limit
        1.07
        upper Limit
        4.10
        value
        2.95
    title
    C1D1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        4.07
        value
        2.04
      2. group Id
        OG001
        lower Limit
        0.97
        upper Limit
        4.99
        value
        2.08
      3. group Id
        OG002
        lower Limit
        1.87
        upper Limit
        7.77
        value
        3.04
      4. group Id
        OG003
        lower Limit
        1.00
        upper Limit
        2.12
        value
        1.08
      5. group Id
        OG004
        lower Limit
        0.57
        upper Limit
        23.7
        value
        2.00
      6. group Id
        OG005
        lower Limit
        0.97
        upper Limit
        2.07
        value
        1.96
      7. group Id
        OG006
        lower Limit
        1.88
        upper Limit
        2.00
        value
        1.98
      8. group Id
        OG007
        lower Limit
        4.05
        upper Limit
        4.08
        value
        4.07
    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
Time to achieve peak plasma concentration 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
Tmax
type
SECONDARY
unit Of Measure
h

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

Preserved source evidence · Not medical advice