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NCT02928224 · OUTCOME

Phase 3: Number of Participants With Clinically Notable Shifts in Serum Chemistry Laboratory Parameters

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

Clinically notable shifts was defined as worsening by at least 2 grades or to \>= Grade 3 based on CTCAE version 4.03 where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening and Grade 5: death.

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

Alanine Aminotransferase - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm11Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm7Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm10Not reportedNot reportedNot reportedNot reported
Albumin - Hypo
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm50Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm16Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm17Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm13Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm12Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm18Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm11Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm7Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm9Not reportedNot reportedNot reportedNot reported
Bilirubin - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm11Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm13Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm12Not reportedNot reportedNot reportedNot reported
Calcium - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm1Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm0Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm0Not reportedNot reportedNot reportedNot reported
Calcium - Hypo
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm15Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm8Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm7Not reportedNot reportedNot reportedNot reported
Creatine Kinase - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm18Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm1Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm3Not reportedNot reportedNot reportedNot reported
Creatinine - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm45Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm11Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm6Not reportedNot reportedNot reportedNot reported
Glucose - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm8Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm16Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm4Not reportedNot reportedNot reportedNot reported
Glucose - Hypo
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm4Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm0Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm1Not reportedNot reportedNot reportedNot reported
Magnesium - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm0Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm1Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm2Not reportedNot reportedNot reportedNot reported
Magnesium - Hypo
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm11Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm4Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm9Not reportedNot reportedNot reportedNot reported
Potassium - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm14Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm10Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm5Not reportedNot reportedNot reportedNot reported
Potassium - Hypo
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm5Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm7Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm9Not reportedNot reportedNot reportedNot reported
Sodium - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm1Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm1Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm2Not reportedNot reportedNot reportedNot reported
Sodium - Hypo
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm10Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm4Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm5Not reportedNot reportedNot reportedNot reported
Troponin I - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm0Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm0Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm0Not reportedNot reportedNot reportedNot reported
Urate - Hyper
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm4Not reportedNot reportedNot reportedNot reported
Phase 3: Doublet Arm2Not reportedNot reportedNot reportedNot reported
Phase 3: Control Arm1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        10
    title
    Alanine Aminotransferase - Hyper
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        17
    title
    Albumin - Hypo
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        18
    title
    Alkaline Phosphatase - Hyper
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        9
    title
    Aspartate Aminotransferase - Hyper
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        12
    title
    Bilirubin - Hyper
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Calcium - Hyper
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        7
    title
    Calcium - Hypo
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
    title
    Creatine Kinase - Hyper
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        6
    title
    Creatinine - Hyper
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        4
    title
    Glucose - Hyper
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Glucose - Hypo
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    Magnesium - Hyper
denoms
  1. counts
    1. group Id
      OG000
      value
      222
    2. group Id
      OG001
      value
      216
    3. group Id
      OG002
      value
      193
    units
    Participants
description
Clinically notable shifts was defined as worsening by at least 2 grades or to \>= Grade 3 based on CTCAE version 4.03 where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening and Grade 5: death.
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 Clinically Notable Shifts in Serum Chemistry Laboratory Parameters
type
SECONDARY
unit Of Measure
Participants

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

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