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NCT02928224 · OUTCOME

Phase 3: Number of Participants With Newly Occurring Clinically Notable Electrocardiogram (ECG) Values

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer · Source last updated 2023-12-21

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
From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)

What was measured

Newly occurring clinically notable changes was defined as participants not meeting the criterion at baseline and meeting criterion post-baseline. The criterion included: heart rate- decrease from baseline \> 25% and to a value \< 50 and increase from baseline \> 25% and to a value \> 100. QT interval- new \> 450 (millisecond) msec, new \> 480 msec, new \> 500 msec, increase from baseline \> 30 msec and increase from baseline \> 60 msec. QTcF- new \> 450 msec, new \> 480 msec, new \> 500 msec, increase from baseline \> 30 msec and increase from baseline \> 60 msec.

Analysis population: The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-treatment assessment, which may have included death. Participants were analyzed according to treatment received.

Groups in this outcome

Phase 3: Triplet Arm

Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.

Phase 3: Doublet Arm

Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.

Phase 3: Control Arm

Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.

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: Triplet Arm222
Phase 3: Doublet Arm216
Phase 3: Control Arm193

Reported measurements

Heart Rate - Decrease from baseline > 25% and to a value < 50
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm1Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm4Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm0Not reportedNot reportedNot reportedNot reported
Heart Rate - Increase from baseline > 25% and to a value > 100
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm27Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm24Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm28Not reportedNot reportedNot reportedNot reported
QT Interval - New > 450 millisecond (msec)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm17Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm30Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm7Not reportedNot reportedNot reportedNot reported
QT Interval - New > 480 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm4Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm7Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm2Not reportedNot reportedNot reportedNot reported
QT Interval - New > 500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm3Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm5Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm0Not reportedNot reportedNot reportedNot reported
QT Interval - increase from baseline > 30 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm97Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm99Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm32Not reportedNot reportedNot reportedNot reported
QT Interval - increase from baseline > 60 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm22Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm21Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm10Not reportedNot reportedNot reportedNot reported
QTcF - New > 450 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm39Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm51Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm23Not reportedNot reportedNot reportedNot reported
QTcF - New > 480 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm9Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm18Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm5Not reportedNot reportedNot reportedNot reported
QTcF - New > 500 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm1Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm6Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm2Not reportedNot reportedNot reportedNot reported
QTcF - increase from baseline > 30 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm59Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm75Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm24Not reportedNot reportedNot reportedNot reported
QTcF - increase from baseline > 60 msec
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm12Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm20Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        0
    title
    Heart Rate - Decrease from baseline > 25% and to a value < 50
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        28
    title
    Heart Rate - Increase from baseline > 25% and to a value > 100
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        30
      3. group Id
        OG002
        value
        7
    title
    QT Interval - New > 450 millisecond (msec)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        2
    title
    QT Interval - New > 480 msec
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        0
    title
    QT Interval - New > 500 msec
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        97
      2. group Id
        OG001
        value
        99
      3. group Id
        OG002
        value
        32
    title
    QT Interval - increase from baseline > 30 msec
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        10
    title
    QT Interval - increase from baseline > 60 msec
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        51
      3. group Id
        OG002
        value
        23
    title
    QTcF - New > 450 msec
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        5
    title
    QTcF - New > 480 msec
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        2
    title
    QTcF - New > 500 msec
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        59
      2. group Id
        OG001
        value
        75
      3. group Id
        OG002
        value
        24
    title
    QTcF - increase from baseline > 30 msec
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        5
    title
    QTcF - increase from baseline > 60 msec
denoms
  1. counts
    1. group Id
      OG000
      value
      222
    2. group Id
      OG001
      value
      216
    3. group Id
      OG002
      value
      193
    units
    Participants
description
Newly occurring clinically notable changes was defined as participants not meeting the criterion at baseline and meeting criterion post-baseline. The criterion included: heart rate- decrease from baseline \> 25% and to a value \< 50 and increase from baseline \> 25% and to a value \> 100. QT interval- new \> 450 (millisecond) msec, new \> 480 msec, new \> 500 msec, increase from baseline \> 30 msec and increase from baseline \> 60 msec. QTcF- new \> 450 msec, new \> 480 msec, new \> 500 msec, increase from baseline \> 30 msec and increase from baseline \> 60 msec.
groups
  1. description
    Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
    id
    OG000
    title
    Phase 3: Triplet Arm
  2. description
    Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.
    id
    OG001
    title
    Phase 3: Doublet Arm
  3. description
    Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.
    id
    OG002
    title
    Phase 3: Control Arm
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-treatment assessment, which may have included death. Participants were analyzed according to treatment received.
reporting Status
POSTED
time Frame
From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
title
Phase 3: Number of Participants With Newly Occurring Clinically Notable Electrocardiogram (ECG) Values
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice