Trial Outcomes & Findings for A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf) (NCT NCT01765543)
NCT ID: NCT01765543
Last Updated: 2016-12-15
Results Overview
AUClast is the area under the vemurafenib plasma concentration versus time curve from time zero to the time of last measured concentration of vemurafenib (Tlast). Area under the curve (AUC) is a measure of the plasma concentration of a drug over time. AUClast is presented in micrograms times (\*) hour per milliliter (mcg\*h/mL).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)
Results posted on
2016-12-15
Participant Flow
A total of 27 participants were enrolled into the study.
Participant milestones
| Measure |
Vemurafenib + Rifampin (All Periods)
There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib (Zelboraf) at a dose of 960 milligrams (mg) as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
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|---|---|
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Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Vemurafenib + Rifampin (All Periods)
There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib (Zelboraf) at a dose of 960 milligrams (mg) as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
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|---|---|
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Overall Study
Death
|
1
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Overall Study
Withdrawal by Subject
|
2
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Baseline Characteristics
A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf)
Baseline characteristics by cohort
| Measure |
Vemurafenib + Rifampin (All Periods)
n=27 Participants
There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
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|---|---|
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Age, Continuous
|
57.9 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)Population: The pharmacokinetics (PK) parameter population included all participants who received both scheduled doses of vemurafenib and who provided adequate PK assessments to calculate important PK parameters.
AUClast is the area under the vemurafenib plasma concentration versus time curve from time zero to the time of last measured concentration of vemurafenib (Tlast). Area under the curve (AUC) is a measure of the plasma concentration of a drug over time. AUClast is presented in micrograms times (\*) hour per milliliter (mcg\*h/mL).
Outcome measures
| Measure |
Vemurafenib (Intervention Period A)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
|
Vemurafenib + Rifampin (Intervention Period C)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
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|---|---|---|
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Area Under the Plasma Concentration Time-curve From Zero to the Last Measurable Concentration Time Point (AUClast) of Vemurafenib
|
125 mcg*h/mL
Geometric Coefficient of Variation 101.4
|
76.7 mcg*h/mL
Geometric Coefficient of Variation 75.3
|
PRIMARY outcome
Timeframe: Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)Population: PK parameter population
AUC(0-inf) is the AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in mcg\*h/mL.
Outcome measures
| Measure |
Vemurafenib (Intervention Period A)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
|
Vemurafenib + Rifampin (Intervention Period C)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
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|---|---|---|
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Area Under the Plasma Concentration Time-curve From Zero to Extrapolated Infinite Time (AUC[0-inf]) of Vemurafenib
|
131 mcg*h/mL
Geometric Coefficient of Variation 104.2
|
78.1 mcg*h/mL
Geometric Coefficient of Variation 74.3
|
PRIMARY outcome
Timeframe: Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)Population: PK parameter population
Cmax is the maximum observed plasma vemurafenib concentration, presented in microgram per milliliter (mcg/mL).
Outcome measures
| Measure |
Vemurafenib (Intervention Period A)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
|
Vemurafenib + Rifampin (Intervention Period C)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
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|---|---|---|
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Maximum Observed Plasma Concentration (Cmax) of Vemurafenib
|
4.45 mcg/mL
Geometric Coefficient of Variation 63.3
|
4.95 mcg/mL
Geometric Coefficient of Variation 59.1
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OTHER_PRE_SPECIFIED outcome
Timeframe: Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)Population: PK parameter population
Tmax is the time from vemurafenib administration to reach Cmax for vemurafenib.
Outcome measures
| Measure |
Vemurafenib (Intervention Period A)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
|
Vemurafenib + Rifampin (Intervention Period C)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
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|---|---|---|
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Time to Reach Cmax (Tmax) of Vemurafenib
|
4.00 hours
Interval 1.98 to 7.92
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4.00 hours
Interval 1.98 to 6.02
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OTHER_PRE_SPECIFIED outcome
Timeframe: Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)Population: PK parameter population
Plasma elimination half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half.
Outcome measures
| Measure |
Vemurafenib (Intervention Period A)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
|
Vemurafenib + Rifampin (Intervention Period C)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
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|---|---|---|
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Plasma Elimination Half Life (t1/2) of Vemurafenib
|
29.7 hours
Standard Deviation 17.6
|
11.6 hours
Standard Deviation 5.24
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OTHER_PRE_SPECIFIED outcome
Timeframe: Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)Population: PK parameter population
Clearance of a drug is a measure of the rate at which a drug is removed (metabolized or eliminated by normal biological processes) from the blood. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Outcome measures
| Measure |
Vemurafenib (Intervention Period A)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
|
Vemurafenib + Rifampin (Intervention Period C)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
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|---|---|---|
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Plasma Apparent Clearance (CL/F) of Vemurafenib
|
7.35 liters/hour
Geometric Coefficient of Variation 104.2
|
12.3 liters/hour
Geometric Coefficient of Variation 74.3
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OTHER_PRE_SPECIFIED outcome
Timeframe: Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)Population: PK parameter population
AUC(0-168) is the AUC from time zero (pre-dose) to 168 hours (time point for last blood sample collection). AUC is a measure of the plasma concentration of a drug over time. AUC(0-168) is presented in mcg\*h/mL.
Outcome measures
| Measure |
Vemurafenib (Intervention Period A)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
|
Vemurafenib + Rifampin (Intervention Period C)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
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|---|---|---|
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Area Under the Plasma Concentration Time-curve From Zero to 168 Hours [AUC(0-168)] of Vemurafenib
|
126 mcg*h/mL
Geometric Coefficient of Variation 99.6
|
78.0 mcg*h/mL
Geometric Coefficient of Variation 74.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)Population: PK parameter population
The AUCpeo, that is, percent area obtained after extrapolation from Tlast to infinity is calculated by using the formula AUCpeo = 100\*(AUC\[0-inf\] minus AUC\[0-last\])/AUC(0-inf). This parameter provides information about what percentage of the theoretical curve AUC(0-inf) is possible to determine experimentally (AUC0-last).
Outcome measures
| Measure |
Vemurafenib (Intervention Period A)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
|
Vemurafenib + Rifampin (Intervention Period C)
n=23 Participants
Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
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|---|---|---|
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Percent Extrapolated AUC(0-inf) (AUCpeo) of Vemurafenib
|
2.75 percent AUC
Geometric Coefficient of Variation 150.4
|
1.26 percent AUC
Geometric Coefficient of Variation 95.9
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Adverse Events
Vemurafenib (Intervention Period A)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Rifampin (Intervention Period B)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Vemurafenib + Rifampin (Intervention Period C)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Vemurafenib + Rifampin (All Periods)
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vemurafenib (Intervention Period A)
n=27 participants at risk
Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
|
Rifampin (Intervention Period B)
n=26 participants at risk
Participants received rifampin alone at a dose of 600 mg as capsules orally once daily from Days 8 through 16.
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Vemurafenib + Rifampin (Intervention Period C)
n=25 participants at risk
Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
|
Vemurafenib + Rifampin (All Periods)
n=27 participants at risk
There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
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|---|---|---|---|---|
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Cardiac disorders
Cardiac arrest
|
0.00%
0/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
0.00%
0/26 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
4.0%
1/25 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
3.7%
1/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
0.00%
0/26 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
4.0%
1/25 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
3.7%
1/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
Other adverse events
| Measure |
Vemurafenib (Intervention Period A)
n=27 participants at risk
Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
|
Rifampin (Intervention Period B)
n=26 participants at risk
Participants received rifampin alone at a dose of 600 mg as capsules orally once daily from Days 8 through 16.
|
Vemurafenib + Rifampin (Intervention Period C)
n=25 participants at risk
Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
|
Vemurafenib + Rifampin (All Periods)
n=27 participants at risk
There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
7.7%
2/26 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
0.00%
0/25 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
7.4%
2/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
1/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
0.00%
0/26 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
4.0%
1/25 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
7.4%
2/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
0.00%
0/26 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
8.0%
2/25 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
7.4%
2/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
3.8%
1/26 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
4.0%
1/25 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
7.4%
2/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
1/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
7.7%
2/26 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
0.00%
0/25 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
11.1%
3/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
1/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
0.00%
0/26 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
4.0%
1/25 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
7.4%
2/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
7.7%
2/26 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
12.0%
3/25 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
14.8%
4/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
19.2%
5/26 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
0.00%
0/25 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
18.5%
5/27 • Day 1 up to 28 days after last dose of study drug (up to 51 days overall)
The safety analysis population included all participants who received at least 1 dose of vemurafenib.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER