TriangleNCT04607421 · OUTCOME
SLI: Area Under the Concentration-time Profile From Time Zero to the Time Tau (AUCtau) of Encorafenib and Its Metabolite LHY746
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Nanogram*hour per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- 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
AUCtau was area under the concentration-time profile from time zero to time tau, the dosing interval. tau = 24 hrs for QD dosing of encorafenib. LHY746 is a metabolite of encorafenib. AUCtau can be calculated directly from the data using 24 hrs (tau) sample or can be approximately calculated by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Analysis population: PK parameter analysis set analyzed. Overall Number of Participants Analyzed: participants evaluable for the outcome measure and Number Analyzed: participants evaluable at specified timepoints. For Cohort 2, Number Analyzed=0 on Cycle 1 Day 1 indicated there was no PK sample at end of dosing interval and kel could not be reliably estimated for calculating AUCtau on specified timepoints. Cohort 1 participants didn't receive encorafenib till Cycle 1 Day 3, hence 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 | Source count |
|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 23 |
| SLI: Cohort 2 [EC + mFOLFOX6] | 15 |
Reported measurements
Encorafenib: Cycle 1 Day 1
| Group | Source count |
|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 0 |
| SLI: Cohort 2 [EC + mFOLFOX6] | 0 |
LHY746: Cycle 1 Day 1
| Group | Source count |
|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 0 |
| SLI: Cohort 2 [EC + mFOLFOX6] | 0 |
Encorafenib: Cycle 1 Day 15
| Group | Source count |
|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 23 |
| SLI: Cohort 2 [EC + mFOLFOX6] | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 13000 | 37 | Not reported | Not reported | Not reported |
| SLI: Cohort 2 [EC + mFOLFOX6] | 9170 | 28.1 | Not reported | Not reported | Not reported |
LHY746: Cycle 1 Day 15
| Group | Source count |
|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 23 |
| SLI: Cohort 2 [EC + mFOLFOX6] | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 8460 | 78.2 | Not reported | Not reported | Not reported |
| SLI: Cohort 2 [EC + mFOLFOX6] | 7740 | 115 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Encorafenib: Cycle 1 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- LHY746: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 37
- value
- 13000
- group Id
- OG001
- spread
- 28.1
- value
- 9170
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Encorafenib: Cycle 1 Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 78.2
- value
- 8460
- group Id
- OG001
- spread
- 115
- value
- 7740
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- LHY746: Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 15
- units
- Participants
- description
- AUCtau was area under the concentration-time profile from time zero to time tau, the dosing interval. tau = 24 hrs for QD dosing of encorafenib. LHY746 is a metabolite of encorafenib. AUCtau can be calculated directly from the data using 24 hrs (tau) sample or can be approximately calculated by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
- dispersion Type
- Geometric Coefficient of Variation
- 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
- GEOMETRIC_MEAN
- population Description
- PK parameter analysis set analyzed. Overall Number of Participants Analyzed: participants evaluable for the outcome measure and Number Analyzed: participants evaluable at specified timepoints. For Cohort 2, Number Analyzed=0 on Cycle 1 Day 1 indicated there was no PK sample at end of dosing interval and kel could not be reliably estimated for calculating AUCtau on specified timepoints. Cohort 1 participants didn't receive encorafenib till Cycle 1 Day 3, hence 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: Area Under the Concentration-time Profile From Time Zero to the Time Tau (AUCtau) of Encorafenib and Its Metabolite LHY746
- type
- SECONDARY
- unit Of Measure
- Nanogram*hour per milliliter
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Preserved source evidence · Not medical advice