TriangleNCT04607421 · OUTCOME
Phase 3: AUC6 of Encorafenib and Its Metabolite LHY746 in Mainland China Participants
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
- Pre-dose (0 hr), 0.5, 1, 2, 3, 4, 5 and 6 hrs post-dose on Days 1 and 15 of Cycle 1
What was measured
The AUC was estimated from time 0 to 6 hours post dose. AUC6 was computed using the Linear/Log trapezoidal method. LHY746 is a metabolite of Encorafenib.
Analysis population: The PK parameter analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. As pre-specified in the protocol of the study, 12 PK evaluable participants in mainland China were randomized in Arm A, no additional participants were required from Arm B and participants did not receive encorafenib in Arm C. Hence, data is reported only for Arm A and not for Arms B and 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.
| Group | Source count |
|---|---|
| Phase 3: Arm A [EC] | 11 |
Reported measurements
Encorafenib: Cycle 1 Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 3: Arm A [EC] | 15400 | 61.2 | Not reported | Not reported | Not reported |
LHY746: Cycle 1 Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 3: Arm A [EC] | 2890 | 63 | Not reported | Not reported | Not reported |
Encorafenib: Cycle 1 Day 15
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 3: Arm A [EC] | 8010 | 41.6 | Not reported | Not reported | Not reported |
LHY746: Cycle 1 Day 15
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 3: Arm A [EC] | 5100 | 83.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 61.2
- value
- 15400
- title
- Encorafenib: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 63
- value
- 2890
- title
- LHY746: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 41.6
- value
- 8010
- title
- Encorafenib: Cycle 1 Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 83.8
- value
- 5100
- title
- LHY746: Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 11
- units
- Participants
- description
- The AUC was estimated from time 0 to 6 hours post dose. AUC6 was computed using the Linear/Log trapezoidal method. LHY746 is a metabolite of Encorafenib.
- 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]
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK parameter analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. As pre-specified in the protocol of the study, 12 PK evaluable participants in mainland China were randomized in Arm A, no additional participants were required from Arm B and participants did not receive encorafenib in Arm C. Hence, data is reported only for Arm A and not for Arms B and C.
- reporting Status
- POSTED
- time Frame
- Pre-dose (0 hr), 0.5, 1, 2, 3, 4, 5 and 6 hrs post-dose on Days 1 and 15 of Cycle 1
- title
- Phase 3: AUC6 of Encorafenib and Its Metabolite LHY746 in Mainland China Participants
- type
- SECONDARY
- unit Of Measure
- Nanogram*hour per milliliter
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice