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NCT04607421 · OUTCOME

Phase 3: Number of Participants According to Response to Patient Global Impression of Change (PGIC) Assessment at Week 30

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer · Source last updated 2026-06-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Week 30

What was measured

The PGIC is a single-item scale where participants rated the overall change in colorectal cancer since participant started taking the study medication as follows: much better, a little better, no change, a little worse, and much worse.

Analysis population: The FAS for Phase 3 included all participants who were randomized in the Phase 3 portion of the study, respectively. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Groups in this outcome

Phase 3: Arm A [EC]

Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.

Phase 3: Arm B [EC + mFOLFOX6]

Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.

Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]

Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 3: Arm A [EC]68
Phase 3: Arm B [EC + mFOLFOX6]140
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]89

Reported measurements

Source class 1

Much better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Arm A [EC]0Not reportedNot reportedNot reportedNot reported
Phase 3: Arm B [EC + mFOLFOX6]0Not reportedNot reportedNot reportedNot reported
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]0Not reportedNot reportedNot reportedNot reported

A little better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Arm A [EC]23Not reportedNot reportedNot reportedNot reported
Phase 3: Arm B [EC + mFOLFOX6]54Not reportedNot reportedNot reportedNot reported
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]39Not reportedNot reportedNot reportedNot reported

No change

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Arm A [EC]27Not reportedNot reportedNot reportedNot reported
Phase 3: Arm B [EC + mFOLFOX6]54Not reportedNot reportedNot reportedNot reported
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]30Not reportedNot reportedNot reportedNot reported

A little worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Arm A [EC]16Not reportedNot reportedNot reportedNot reported
Phase 3: Arm B [EC + mFOLFOX6]26Not reportedNot reportedNot reportedNot reported
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]15Not reportedNot reportedNot reportedNot reported

Much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Arm A [EC]2Not reportedNot reportedNot reportedNot reported
Phase 3: Arm B [EC + mFOLFOX6]6Not reportedNot reportedNot reportedNot reported
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      title
      Much better
    2. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        54
      3. group Id
        OG002
        value
        39
      title
      A little better
    3. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        54
      3. group Id
        OG002
        value
        30
      title
      No change
    4. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        26
      3. group Id
        OG002
        value
        15
      title
      A little worse
    5. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        5
      title
      Much worse
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    2. group Id
      OG001
      value
      140
    3. group Id
      OG002
      value
      89
    units
    Participants
description
The PGIC is a single-item scale where participants rated the overall change in colorectal cancer since participant started taking the study medication as follows: much better, a little better, no change, a little worse, and much worse.
groups
  1. description
    Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    OG000
    title
    Phase 3: Arm A [EC]
  2. description
    Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    OG001
    title
    Phase 3: Arm B [EC + mFOLFOX6]
  3. description
    Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.
    id
    OG002
    title
    Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]
param Type
COUNT_OF_PARTICIPANTS
population Description
The FAS for Phase 3 included all participants who were randomized in the Phase 3 portion of the study, respectively. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Week 30
title
Phase 3: Number of Participants According to Response to Patient Global Impression of Change (PGIC) Assessment at Week 30
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice