NCT04607421 · OUTCOME
Phase 3: Trough Plasma Concentration of Encorafenib and Its Metabolite LHY746
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
- GEOMETRIC_MEAN
- Unit
- Nanograms per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Predose on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1
What was measured
Trough plasma concentration of encorafenib and its metabolite LHY746 was measured in this outcome measure.
Analysis population: The PK concentration set was defined as all enrolled participants who were treated and had at least 1 analyte concentration. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable at specified timepoints. Participants received encorafenib in Arms A and B of Phase 3, hence data is reported only for Arms A and B and not for Arm C.
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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 91 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 118 |
|---|
Reported measurements
Encorafenib: Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 91 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 113 |
|---|
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 116.2 | 3892 | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | NA | NA | Not reported | Not reported | Geometric mean and geometric coefficient of variation could not be estimated as only 2 observations were above lower limit of quantification and individual value were 6100 and 6100 nanograms per milliliter. |
|---|
Encorafenib: Cycle 2 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 86 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 113 |
|---|
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 10.44 | 180 | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 15.69 | 229 | Not reported | Not reported | Not reported |
|---|
Encorafenib: Cycle 3 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 83 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 118 |
|---|
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 10.60 | 137 | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 13.07 | 179 | Not reported | Not reported | Not reported |
|---|
Encorafenib: Cycle 4 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 80 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 115 |
|---|
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 9.926 | 193 | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 17.37 | 169 | Not reported | Not reported | Not reported |
|---|
Encorafenib: Cycle 5 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 75 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 107 |
|---|
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 10.02 | 217 | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 17.13 | 201 | Not reported | Not reported | Not reported |
|---|
Encorafenib: Cycle 6 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 57 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 97 |
|---|
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 11.74 | 169 | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 15.03 | 143 | Not reported | Not reported | Not reported |
|---|
LHY746: Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 91 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 113 |
|---|
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 35.54 | 549 | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | NA | NA | Not reported | Not reported | Geometric mean and geometric coefficient of variation could not be estimated as only 1 observation was above lower limit of quantification and individual value was 239 nanograms per milliliter. |
|---|
LHY746: Cycle 2 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 86 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 113 |
|---|
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 44.71 | 251 | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 62.90 | 213 | Not reported | Not reported | Not reported |
|---|
LHY746: Cycle 3 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 83 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 118 |
|---|
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 50.36 | 178 | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 61.88 | 220 | Not reported | Not reported | Not reported |
|---|
LHY746: Cycle 4 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 80 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 115 |
|---|
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 41.61 | 224 | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 76.79 | 205 | Not reported | Not reported | Not reported |
|---|
LHY746: Cycle 5 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 75 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 107 |
|---|
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 37.87 | 242 | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 66.29 | 192 | Not reported | Not reported | Not reported |
|---|
LHY746: Cycle 6 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 57 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 97 |
|---|
Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 58.59 | 250 | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 72.39 | 212 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3892
- value
- 116.2
- comment
- Geometric mean and geometric coefficient of variation could not be estimated as only 2 observations were above lower limit of quantification and individual value were 6100 and 6100 nanograms per milliliter.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 113
- units
- Participants
- title
- Encorafenib: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 180
- value
- 10.44
- group Id
- OG001
- spread
- 229
- value
- 15.69
- denoms
- counts
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 113
- units
- Participants
- title
- Encorafenib: Cycle 2 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 137
- value
- 10.60
- group Id
- OG001
- spread
- 179
- value
- 13.07
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 118
- units
- Participants
- title
- Encorafenib: Cycle 3 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 193
- value
- 9.926
- group Id
- OG001
- spread
- 169
- value
- 17.37
- denoms
- counts
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 115
- units
- Participants
- title
- Encorafenib: Cycle 4 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 217
- value
- 10.02
- group Id
- OG001
- spread
- 201
- value
- 17.13
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 107
- units
- Participants
- title
- Encorafenib: Cycle 5 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 169
- value
- 11.74
- group Id
- OG001
- spread
- 143
- value
- 15.03
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 97
- units
- Participants
- title
- Encorafenib: Cycle 6 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 549
- value
- 35.54
- comment
- Geometric mean and geometric coefficient of variation could not be estimated as only 1 observation was above lower limit of quantification and individual value was 239 nanograms per milliliter.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 113
- units
- Participants
- title
- LHY746: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 251
- value
- 44.71
- group Id
- OG001
- spread
- 213
- value
- 62.90
- denoms
- counts
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 113
- units
- Participants
- title
- LHY746: Cycle 2 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 178
- value
- 50.36
- group Id
- OG001
- spread
- 220
- value
- 61.88
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 118
- units
- Participants
- title
- LHY746: Cycle 3 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 224
- value
- 41.61
- group Id
- OG001
- spread
- 205
- value
- 76.79
- denoms
- counts
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 115
- units
- Participants
- title
- LHY746: Cycle 4 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 242
- value
- 37.87
- group Id
- OG001
- spread
- 192
- value
- 66.29
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 107
- units
- Participants
- title
- LHY746: Cycle 5 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 250
- value
- 58.59
- group Id
- OG001
- spread
- 212
- value
- 72.39
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 97
- units
- Participants
- title
- LHY746: Cycle 6 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 118
- units
- Participants
- description
- Trough plasma concentration of encorafenib and its metabolite LHY746 was measured in this outcome measure.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- 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]
- 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]
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK concentration set was defined as all enrolled participants who were treated and had at least 1 analyte concentration. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable at specified timepoints. Participants received encorafenib in Arms A and B of Phase 3, hence data is reported only for Arms A and B and not for Arm C.
- reporting Status
- POSTED
- time Frame
- Predose on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1
- title
- Phase 3: Trough Plasma Concentration of Encorafenib and Its Metabolite LHY746
- type
- SECONDARY
- unit Of Measure
- Nanograms per milliliter
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