NCT04607421 · OUTCOME
SLI: Time to Maximum Plasma Concentration (Tmax) 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
- MEDIAN
- Unit
- Hours
- Interval / dispersion
- Full Range
- Time frame
- Cohort 1: Pre-dose (0 hr), 0.75, 1.5, 2.5, 3.5, 5.5, 7.5, and 48 hrs post-dose on Day 15 of Cycle 1; Cohort 2: Pre-dose (0 hr), 1, 2, 3, 4, 6, 8, and 48 hrs post-dose on Days 1 and 15 of Cycle 1
What was measured
Tmax: time (hours) to Cmax. LHY746 is a metabolite of Encorafenib.
Analysis population: PK parameter analysis set: all enrolled participants treated who had sufficient information to estimate at least 1 of PK parameters of interest and had no major protocol deviations affecting PK assessment. Overall Number of Participants Analyzed: participants evaluable for the outcome measure and Number Analyzed: participants evaluable at specified timepoints. Cohort 1 participants did not receive encorafenib until Cycle 1 Day 3, so there was no analysis done at Cycle 1 Day 1.
Groups in this outcome
SLI: Cohort 1 [EC + FOLFIRI]
Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (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 irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
SLI: Cohort 2 [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 |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 23 |
|---|
| SLI: Cohort 2 [EC + mFOLFOX6] | 23 |
|---|
Reported measurements
Encorafenib: Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 0 |
|---|
| SLI: Cohort 2 [EC + mFOLFOX6] | 23 |
|---|
Values in Hours · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SLI: Cohort 2 [EC + mFOLFOX6] | 2.77 | Not reported | 1.08 | 6 | Not reported |
|---|
LHY746: Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 0 |
|---|
| SLI: Cohort 2 [EC + mFOLFOX6] | 23 |
|---|
Values in Hours · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SLI: Cohort 2 [EC + mFOLFOX6] | 7.28 | Not reported | 3 | 8.15 | Not reported |
|---|
Encorafenib: Cycle 1 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 23 |
|---|
| SLI: Cohort 2 [EC + mFOLFOX6] | 16 |
|---|
Values in Hours · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 2.32 | Not reported | 1.43 | 5.33 | Not reported |
|---|
| SLI: Cohort 2 [EC + mFOLFOX6] | 2.16 | Not reported | 0.983 | 6 | Not reported |
|---|
LHY746: Cycle 1 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 23 |
|---|
| SLI: Cohort 2 [EC + mFOLFOX6] | 16 |
|---|
Values in Hours · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 5.25 | Not reported | 1.5 | 6.87 | Not reported |
|---|
| SLI: Cohort 2 [EC + mFOLFOX6] | 3.98 | Not reported | 1 | 8 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 1.08
- upper Limit
- 6
- value
- 2.77
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 23
- units
- Participants
- title
- Encorafenib: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG001
- lower Limit
- 3
- upper Limit
- 8.15
- value
- 7.28
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 23
- units
- Participants
- title
- LHY746: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.43
- upper Limit
- 5.33
- value
- 2.32
- group Id
- OG001
- lower Limit
- 0.983
- upper Limit
- 6
- value
- 2.16
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 16
- units
- Participants
- title
- Encorafenib: Cycle 1 Day 15
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.5
- upper Limit
- 6.87
- value
- 5.25
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 8
- value
- 3.98
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 16
- units
- Participants
- title
- LHY746: Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 23
- units
- Participants
- description
- Tmax: time (hours) to Cmax. LHY746 is a metabolite of Encorafenib.
- dispersion Type
- Full Range
- groups
- description
- Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (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 irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
- id
- OG000
- title
- SLI: Cohort 1 [EC + FOLFIRI]
- 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
- SLI: Cohort 2 [EC + mFOLFOX6]
- param Type
- MEDIAN
- population Description
- PK parameter analysis set: all enrolled participants treated who had sufficient information to estimate at least 1 of PK parameters of interest and had no major protocol deviations affecting PK assessment. Overall Number of Participants Analyzed: participants evaluable for the outcome measure and Number Analyzed: participants evaluable at specified timepoints. Cohort 1 participants did not receive encorafenib until Cycle 1 Day 3, so there was no analysis done at Cycle 1 Day 1.
- reporting Status
- POSTED
- time Frame
- Cohort 1: Pre-dose (0 hr), 0.75, 1.5, 2.5, 3.5, 5.5, 7.5, and 48 hrs post-dose on Day 15 of Cycle 1; Cohort 2: Pre-dose (0 hr), 1, 2, 3, 4, 6, 8, and 48 hrs post-dose on Days 1 and 15 of Cycle 1
- title
- SLI: Time to Maximum Plasma Concentration (Tmax) of Encorafenib and Its Metabolite LHY746
- type
- SECONDARY
- unit Of Measure
- Hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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