Trial Outcomes & Findings for A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations (NCT NCT05446142)
NCT ID: NCT05446142
Last Updated: 2024-02-23
Results Overview
AUCinf for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by AUClast + (Clast/kel), where AUClast was the area under the plasma concentration-time profile from time zero to last quantifiable concentration, Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was first-order elimination rate constant.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose
Results posted on
2024-02-23
Participant Flow
A total of 18 participants were enrolled and randomized into 1 of the 6 treatment sequences.
Participant milestones
| Measure |
Encorafenib 75 mg eMCC=>75 mg eMCCL=>75 mg CAP=>75 mg eMCC+20 mg Rabeprazole
Period 1: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 2: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 3: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCC on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.
|
Encorafenib 75 mg eMCC=>75 mg CAP=>75 mg eMCCL=>75 mg eMCCL+20 mg Rabeprazole
Period 1: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 2: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 3: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCCL on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.
|
Encorafenib 75 mg eMCCL=>75 mg CAP=>75 mg eMCC=>75 mg eMCC+20 mg Rabeprazole
Period 1: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 2: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 3: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCC on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.
|
Encorafenib 75 mg eMCCL=>75 m eMCC=>75 mg CAP=>75 mg eMCCL+20 mg Rabeprazole
Period 1: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 2: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 3: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCCL on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.
|
Encorafenib 75 mg CAP=>75 mg eMCC=>75 mg eMCCL=>75 mg eMCC+20 mg Rabeprazole
Period 1: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 2: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 3: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCC on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.
|
Encorafenib 75 mg CAP=>75 mg eMCCL=>75 mg eMCC=>75 mg eMCCL+20 mg Rabeprazole
Period 1: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 2: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 3: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCCL on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.
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|---|---|---|---|---|---|---|
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Period 1
STARTED
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3
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3
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3
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3
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3
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3
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Period 1
COMPLETED
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3
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3
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3
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3
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3
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3
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Period 1
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Period 2
STARTED
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3
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3
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3
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3
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3
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3
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Period 2
COMPLETED
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2
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3
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3
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3
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3
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3
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Period 2
NOT COMPLETED
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1
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0
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0
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0
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0
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0
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Period 3
STARTED
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2
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3
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3
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3
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3
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3
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Period 3
COMPLETED
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2
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3
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3
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3
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3
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3
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Period 3
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Period 4
STARTED
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2
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3
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3
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3
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3
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3
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Period 4
COMPLETED
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2
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3
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3
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3
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3
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3
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Period 4
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
Encorafenib 75 mg eMCC=>75 mg eMCCL=>75 mg CAP=>75 mg eMCC+20 mg Rabeprazole
Period 1: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 2: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 3: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCC on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.
|
Encorafenib 75 mg eMCC=>75 mg CAP=>75 mg eMCCL=>75 mg eMCCL+20 mg Rabeprazole
Period 1: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 2: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 3: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCCL on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.
|
Encorafenib 75 mg eMCCL=>75 mg CAP=>75 mg eMCC=>75 mg eMCC+20 mg Rabeprazole
Period 1: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 2: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 3: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCC on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.
|
Encorafenib 75 mg eMCCL=>75 m eMCC=>75 mg CAP=>75 mg eMCCL+20 mg Rabeprazole
Period 1: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 2: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 3: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCCL on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.
|
Encorafenib 75 mg CAP=>75 mg eMCC=>75 mg eMCCL=>75 mg eMCC+20 mg Rabeprazole
Period 1: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 2: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 3: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCC on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.
|
Encorafenib 75 mg CAP=>75 mg eMCCL=>75 mg eMCC=>75 mg eMCCL+20 mg Rabeprazole
Period 1: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 2: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 3: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose.
Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCCL on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.
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Period 2
Adverse Event
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1
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0
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0
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0
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0
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0
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Baseline Characteristics
A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations
Baseline characteristics by cohort
| Measure |
All Participants
n=18 Participants
All participants enrolled in this study
|
|---|---|
|
Age, Continuous
Mean (SD)
|
46.5 Years
STANDARD_DEVIATION 15.93 • n=99 Participants
|
|
Age, Customized
18-44 Years
|
9 Participants
n=99 Participants
|
|
Age, Customized
45-64 Years
|
7 Participants
n=99 Participants
|
|
Age, Customized
>=65 Years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American, White
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdosePopulation: The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.
AUCinf for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by AUClast + (Clast/kel), where AUClast was the area under the plasma concentration-time profile from time zero to last quantifiable concentration, Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was first-order elimination rate constant.
Outcome measures
| Measure |
75 mg Encorafenib eMCC, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.
|
75mg Encorafenib eMCCL, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.
|
75mg Encorafenib CAP, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.
|
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
n=7 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.
|
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
n=9 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
|
2895 ng*hr/mL
Geometric Coefficient of Variation 44
|
2909 ng*hr/mL
Geometric Coefficient of Variation 49
|
2957 ng*hr/mL
Geometric Coefficient of Variation 41
|
2825 ng*hr/mL
Geometric Coefficient of Variation 35
|
2556 ng*hr/mL
Geometric Coefficient of Variation 63
|
PRIMARY outcome
Timeframe: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdosePopulation: The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.
Cmax for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were observed directly from data.
Outcome measures
| Measure |
75 mg Encorafenib eMCC, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.
|
75mg Encorafenib eMCCL, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.
|
75mg Encorafenib CAP, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.
|
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
n=8 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.
|
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
n=9 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
|
898.4 ng/mL
Geometric Coefficient of Variation 46
|
778.2 ng/mL
Geometric Coefficient of Variation 45
|
845.8 ng/mL
Geometric Coefficient of Variation 36
|
686.0 ng/mL
Geometric Coefficient of Variation 43
|
631.7 ng/mL
Geometric Coefficient of Variation 70
|
PRIMARY outcome
Timeframe: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdosePopulation: The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.
AUClast for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated using Linear/Log trapezoidal method.
Outcome measures
| Measure |
75 mg Encorafenib eMCC, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.
|
75mg Encorafenib eMCCL, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.
|
75mg Encorafenib CAP, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.
|
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
n=8 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.
|
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
n=9 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Last Quantifiable Concentration (AUClast) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
|
2879 ng*hr/mL
Geometric Coefficient of Variation 44
|
2858 ng*hr/mL
Geometric Coefficient of Variation 48
|
2934 ng*hr/mL
Geometric Coefficient of Variation 41
|
2635 ng*hr/mL
Geometric Coefficient of Variation 37
|
2529 ng*hr/mL
Geometric Coefficient of Variation 65
|
SECONDARY outcome
Timeframe: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdosePopulation: The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.
Tmax for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were observed directly from data as time of first occurrence.
Outcome measures
| Measure |
75 mg Encorafenib eMCC, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.
|
75mg Encorafenib eMCCL, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.
|
75mg Encorafenib CAP, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.
|
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
n=8 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.
|
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
n=9 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
|
|---|---|---|---|---|---|
|
Time for Cmax (Tmax) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
|
1.00 hr
Interval 0.5 to 3.0
|
1.00 hr
Interval 1.0 to 1.5
|
1.5 hr
Interval 1.0 to 3.0
|
1.25 hr
Interval 1.0 to 2.52
|
1.00 hr
Interval 0.5 to 3.0
|
SECONDARY outcome
Timeframe: Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdosePopulation: The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.
t½ for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
Outcome measures
| Measure |
75 mg Encorafenib eMCC, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.
|
75mg Encorafenib eMCCL, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.
|
75mg Encorafenib CAP, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.
|
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
n=7 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.
|
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
n=9 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
|
|---|---|---|---|---|---|
|
Terminal Half-Life (t½) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
|
4.691 hour
Standard Deviation 1.5680
|
4.850 hour
Standard Deviation 2.0588
|
4.730 hour
Standard Deviation 1.7416
|
4.710 hour
Standard Deviation 2.3714
|
5.350 hour
Standard Deviation 2.0893
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdosePopulation: The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.
CL/F for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by Dose/AUCinf after oral dose.
Outcome measures
| Measure |
75 mg Encorafenib eMCC, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.
|
75mg Encorafenib eMCCL, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.
|
75mg Encorafenib CAP, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.
|
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
n=7 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.
|
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
n=9 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
|
|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
|
25.91 L/hr
Geometric Coefficient of Variation 44
|
25.81 L/hr
Geometric Coefficient of Variation 49
|
25.38 L/hr
Geometric Coefficient of Variation 41
|
26.53 L/hr
Geometric Coefficient of Variation 34
|
29.34 L/hr
Geometric Coefficient of Variation 64
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdosePopulation: The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.
Vz/F for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by Dose/(AUCinf \* kel) after oral dose.
Outcome measures
| Measure |
75 mg Encorafenib eMCC, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.
|
75mg Encorafenib eMCCL, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.
|
75mg Encorafenib CAP, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.
|
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
n=7 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.
|
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
n=9 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
|
166.1 Liters
Geometric Coefficient of Variation 46
|
165.1 Liters
Geometric Coefficient of Variation 49
|
161.7 Liters
Geometric Coefficient of Variation 46
|
159.3 Liters
Geometric Coefficient of Variation 29
|
209 Liters
Geometric Coefficient of Variation 56
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 after the last encorafenib dose (the total duration of the study was approximately 60 days from baseline)Population: All participants randomly assigned to a treatment sequence and who took at least 1 dose of encorafenib. Participants were analyzed according to the formulation they actually received.
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Any AEs occurring following start of treatment were considered as treatment emergent adverse event (TEAE). Events that occurred during follow-up within the lag time of up to 28 days after the last encorafenib dose were counted as treatment emergent and attributed to the last treatment taken. Events that occurred during the washout period (up to 28 days from the last treatment) between study periods were counted as treatment emergent and attributed to the previous treatment taken.
Outcome measures
| Measure |
75 mg Encorafenib eMCC, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.
|
75mg Encorafenib eMCCL, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.
|
75mg Encorafenib CAP, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.
|
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
n=8 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.
|
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
n=9 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with AEs (Treatment related)
|
11 Participants
|
9 Participants
|
8 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with SAEs (All Causalities)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with severe (including fatal) adverse events (All Causalities)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with AEs (All Causalities)
|
11 Participants
|
11 Participants
|
8 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, and at early discontinuation or at the discretion of the investigator (the total duration of the study was approximately 60 days from baseline)Population: All participants randomly assigned to a treatment sequence and who took at least 1 dose of encorafenib. Participants were analyzed according to the formulation they actually received. Specifically, number of participants analyzed in the table is the total number of participants with at least one observation of the given laboratory test while on study treatment or during lag time.
Haematological, clinical chemistry (serum) and urinalysis safety tests were assessed against the criteria specified in the sponsor reporting standards. The assessment did not take into account whether each participants's baseline test result was within or outside the laboratory reference range for the particular laboratory parameter. The baseline measurement for safety laboratory tests for all periods was the predose measurement on Day -1 of Period 1. Only those categories in which at least 1 participant had data were reported.
Outcome measures
| Measure |
75 mg Encorafenib eMCC, Fasted
Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.
|
75mg Encorafenib eMCCL, Fasted
n=1 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.
|
75mg Encorafenib CAP, Fasted
Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.
|
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
n=8 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.
|
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
n=9 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
HEMATOLOGY - Monocytes/Leukocytes (%) > 1.2 x Upper Limit of Normal (ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
CLINICAL CHEMISTRY - Urate (mg/dL) > 1.2x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
URINALYSIS - Urobilinogen (EU) >= 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, 0 and 2 hours postdose in each period, and at early discontinuation (the total duration of the study was approximately 60 days from baseline)Population: All participants randomly assigned to a treatment sequence and who took at least 1 dose of encorafenib. Participants were analyzed according to the formulation they actually received.
Supine blood pressure (BP) and pulse rate (PR) were measured at times specified. For Periods 1 to 3, the baseline measurement was the predose measurement on Day -1 of each period. For Period 4, the baseline measurement was the predose measurement on Day -1 of Period 3. The reported categories included: systolic blood pressure (SBP)\>=90mmHg; change from baseline (CFB) in SBP\>=30mmHg; diastolic blood pressure (DBP)\<50mmHg; CFB in DBP\>=20mmHg; PR\<40 beats per minute (bpm) or PR\>120bpm. Only those categories in which at least 1 participant had data were provided.
Outcome measures
| Measure |
75 mg Encorafenib eMCC, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.
|
75mg Encorafenib eMCCL, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.
|
75mg Encorafenib CAP, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.
|
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
n=8 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.
|
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
n=9 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
|
|---|---|---|---|---|---|
|
Number of Participants Meeting Vital Signs Categorical Criteria
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 0 and 2 hours postdose in each period, and at early discontinuation (the total duration of the study was approximately 60 days from baseline)Population: All participants randomly assigned to a treatment sequence and who took at least 1 dose of encorafenib. Participants were analyzed according to the formulation they actually received.
Absolute values and changes from baseline in PR, QT, QRS, heart rate and QTcF were summarized by protocol pre-defined categorization criterion. QTcF were derived using Fridericia's heart rate correction formula. For each period, triplicate ECGs were conducted predose on Day 1; all other ECG measurements were single ECGs. The baseline ECG value was the average of the triplicate ECG measurements collected before dose administration on Day 1. Changes from baseline were defined as the change between the postdose ECG measurement and the derived baseline ECG.
Outcome measures
| Measure |
75 mg Encorafenib eMCC, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.
|
75mg Encorafenib eMCCL, Fasted
n=18 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.
|
75mg Encorafenib CAP, Fasted
n=17 Participants
Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.
|
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
n=8 Participants
Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.
|
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
n=9 Participants
Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
|
|---|---|---|---|---|---|
|
Number of Participnts With Clinically Significant Electrocardiogram (ECG) Abnormalities
QT INTERVAL (MSEC) Value >=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participnts With Clinically Significant Electrocardiogram (ECG) Abnormalities
QTCF (MSEC) 450 msec <= Value < 480 msec or 480 msec <= Value < 500 msec or Value > 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participnts With Clinically Significant Electrocardiogram (ECG) Abnormalities
PR INTERVAL (MSEC) value >= 300 msec or %Chg>=25/50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participnts With Clinically Significant Electrocardiogram (ECG) Abnormalities
QRS COMPLEX (MSEC) Value >=140 msec or %Chg>=50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participnts With Clinically Significant Electrocardiogram (ECG) Abnormalities
QTCF (MSEC) 30 msec <= Chg < 60 msec or Chg > 60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
75 mg Encorafenib eMCC, Fasted
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
75 mg Encorafenib eMCCL, Fasted
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
75 mg Encorafenib CAP, Fasted
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
75 mg Encorafenib eMCC, Fasted
n=18 participants at risk
Participants received a single ora l dose of encorafenib 75 mg eMCC under fasted condition.
|
75 mg Encorafenib eMCCL, Fasted
n=18 participants at risk
Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.
|
75 mg Encorafenib CAP, Fasted
n=17 participants at risk
Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.
|
75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
n=8 participants at risk
Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.
|
75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
n=9 participants at risk
Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
|
|---|---|---|---|---|---|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
5.9%
1/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
5.9%
1/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.1%
1/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Eye disorders
Eye pain
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
5.9%
1/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
12.5%
1/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
5.9%
1/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.1%
1/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
General disorders
Chills
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.1%
1/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
General disorders
Facial pain
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.1%
1/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
General disorders
Fatigue
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.1%
2/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
General disorders
Feeling hot
|
22.2%
4/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
22.2%
4/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
5.9%
1/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.1%
1/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.1%
2/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
5.9%
1/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.1%
1/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.1%
2/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
29.4%
5/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
12.5%
1/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
22.2%
2/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.1%
2/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.1%
1/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Skin and subcutaneous tissue disorders
Pseudofolliculitis
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.1%
1/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Vascular disorders
Flushing
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.1%
2/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
|
Vascular disorders
Hot flush
|
0.00%
0/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
5.6%
1/18 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
11.8%
2/17 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/8 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
0.00%
0/9 • Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place