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NCT03989115 · OUTCOME

Duration of Response (DOR)

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
day(s)
Interval / dispersion
95% Confidence Interval
Time frame
Response assessment occurs from the start of intervention until the date of documented disease progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first.

What was measured

Duration of response of RMC-4630 and cobimetinib or RMC-4630 and osimertinib per RECIST v1.1

Analysis population: There were insufficient number of participants with events to calculate.

Groups in this outcome

Intermittent RMC-4630 (D1D4 or D1D2) + Daily Cobimetinib (QD21/7)

Participants who received intermittent dose of RMC-4630 80 mg or 140 mg on D1 and D4 or on D1 and D2 of a 28-day cycle and daily dose of Cobimetinib 20 mg or 40 mg from D1 through D21 and then 7 days off Cobimetinib from D22 to D28 of a 28-day cycle.

Intermittent RMC-4630 (D1D2) + Intermittent Cobimetinib (D1D2)

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and intermittent dose of Cobimetinib 40 mg or 60 mg on D1 and D2 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 (D1D4 or D1D2) + Daily Cobimetinib (QD21/7)0
Intermittent RMC-4630 (D1D2) + Intermittent Cobimetinib (D1D2)0
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)0
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)0
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)1
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D20
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)0
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)0

Reported measurements

Source class 1
Values in day(s) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)NANot reportedNot reportedNot reportedinsufficient number of participants with events to calculate
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        insufficient number of participants with events to calculate
        group Id
        OG004
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    units
    Participants
description
Duration of response of RMC-4630 and cobimetinib or RMC-4630 and osimertinib per RECIST v1.1
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants who received intermittent dose of RMC-4630 80 mg or 140 mg on D1 and D4 or on D1 and D2 of a 28-day cycle and daily dose of Cobimetinib 20 mg or 40 mg from D1 through D21 and then 7 days off Cobimetinib from D22 to D28 of a 28-day cycle.
    id
    OG000
    title
    Intermittent RMC-4630 (D1D4 or D1D2) + Daily Cobimetinib (QD21/7)
  2. description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and intermittent dose of Cobimetinib 40 mg or 60 mg on D1 and D2 of a 28-day cycle.
    id
    OG001
    title
    Intermittent RMC-4630 (D1D2) + Intermittent Cobimetinib (D1D2)
  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
population Description
There were insufficient number of participants with events to calculate.
reporting Status
POSTED
time Frame
Response assessment occurs from the start of intervention until the date of documented disease progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first.
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
day(s)

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

Preserved source evidence · Not medical advice