Trial Outcomes & Findings for A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma (NCT NCT00949702)
NCT ID: NCT00949702
Last Updated: 2017-07-25
Results Overview
BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.
COMPLETED
PHASE2
132 participants
From first treatment through September 27, 2010
2017-07-25
Participant Flow
Participant milestones
| Measure |
Vemurafenib 960 mg
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Overall Study
STARTED
|
132
|
|
Overall Study
COMPLETED
|
84
|
|
Overall Study
NOT COMPLETED
|
48
|
Reasons for withdrawal
| Measure |
Vemurafenib 960 mg
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Overall Study
Death
|
40
|
|
Overall Study
Disease progression
|
7
|
|
Overall Study
Withdrawal of consent
|
1
|
Baseline Characteristics
A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Vemurafenib 960 mg
n=132 Participants
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 14.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first treatment through September 27, 2010Population: Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.
Outcome measures
| Measure |
Vemurafenib 960 mg
n=132 Participants
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
|
52.3 Percentage of participants
Interval 43.4 to 61.0
|
SECONDARY outcome
Timeframe: From first treatment through September 27, 2010Population: Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.
Outcome measures
| Measure |
Vemurafenib 960 mg
n=132 Participants
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
|
54.5 Percentage of participants
Interval 45.7 to 63.2
|
SECONDARY outcome
Timeframe: From first treatment through September 27, 2010Population: Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those patients whose best overall response was complete response or partial response. PD: At least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion. For patients who were alive without progression, duration of response was censored on the date of the last evaluable tumor assessment.
Outcome measures
| Measure |
Vemurafenib 960 mg
n=69 Participants
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
|
6.5 Months
Interval 5.6 to
The upper limit of the confidence interval was not estimable because a large percentage of patients (57%) were progression-free at the data cutoff date and had censored data.
|
SECONDARY outcome
Timeframe: From first treatment through September 27, 2010Population: Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed complete response (CR) or partial response (PR), whichever occurred first.
Outcome measures
| Measure |
Vemurafenib 960 mg
n=69 Participants
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
|
1.38 Months
Interval 1.3 to 1.6
|
SECONDARY outcome
Timeframe: From first treatment through September 27, 2010Population: Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in patients without disease progression were considered to be a PFS event on the date of death. Patients who neither progressed nor died were censored on the date of the last evaluable tumor assessment prior to the data cutoff date.
Outcome measures
| Measure |
Vemurafenib 960 mg
n=132 Participants
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
|
6.1 Months
Interval 5.5 to 6.9
|
SECONDARY outcome
Timeframe: From first treatment through September 27, 2010Population: Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
Overall survival was defined as the time from the date of the first treatment to the date of death, regardless of the cause of death. For patients who were alive at the time of analysis, overall survival was censored at the last date the patient was known to be alive prior to the data cutoff date.
Outcome measures
| Measure |
Vemurafenib 960 mg
n=132 Participants
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Overall Survival
|
NA Months
Interval 9.5 to
The median and the upper limit of the confidence interval were not estimable because a large percentage of patients (69%) were alive at the data cutoff date.
|
SECONDARY outcome
Timeframe: From first treatment through September 27, 2010Population: Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
Three parameters were measured. (1) Improvement in the Physician's Assessment of Global Performance status on a 7-point scale (1=very much better to 7=very much worse). (2) Improvement in oxygen saturation requirements, defined as a clinically meaningful increase in oxygen saturation requirement (from a baseline value \< 95% to ≥ 95% saturation using a pulse oximeter). (3) A decrease in total dose and frequency of narcotic pain analgesics. The percentage of patients showing improvement (1 and 2) or a decrease (3) are reported.
Outcome measures
| Measure |
Vemurafenib 960 mg
n=132 Participants
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Improvement in Physical Symptoms (Improvement in Physician's Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline
Improvement in performance status
|
83.3 Percentage of participants
Interval 80.0 to 90.0
|
|
Improvement in Physical Symptoms (Improvement in Physician's Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline
Improvement in oxygen saturation requirement
|
4.5 Percentage of participants
Interval 0.0 to 10.0
|
|
Improvement in Physical Symptoms (Improvement in Physician's Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline
Decrease in use of narcotic pain analgesics
|
3.0 Percentage of participants
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Pre-dose to 8 hours post-dose on Day 15 of Cycle 1Population: Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.
Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin).
Outcome measures
| Measure |
Vemurafenib 960 mg
n=87 Participants
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1
|
56.73 μg/mL
Standard Deviation 21.76
|
SECONDARY outcome
Timeframe: Pre-dose to 8 hours post-dose on Day 15 of Cycle 1Population: Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.
Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). AUC0-8h was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Vemurafenib 960 mg
n=87 Participants
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1
|
380.16 μg⋅h/mL
Standard Deviation 143.56
|
SECONDARY outcome
Timeframe: Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1Population: Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.
Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and 4 hours post-dose at Day 1 of Cycles 1, 2, 3, 4, 6, 8, and 10. Each Cycle was 3 weeks in duration.
Outcome measures
| Measure |
Vemurafenib 960 mg
n=122 Participants
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Vemurafenib Plasma Levels at Various Treatment Cycles
Pre-dose Cycle 8 Day 1, n=71
|
50.42 μg/mL
Standard Deviation 22.06
|
|
Vemurafenib Plasma Levels at Various Treatment Cycles
Pre-dose Cycle 1 Day 15, n=108
|
47.55 μg/mL
Standard Deviation 23.14
|
|
Vemurafenib Plasma Levels at Various Treatment Cycles
Pre-dose Cycle 2 Day 1, n=122
|
41.12 μg/mL
Standard Deviation 23.39
|
|
Vemurafenib Plasma Levels at Various Treatment Cycles
Pre-dose Cycle 3 Day 1, n=109
|
45.20 μg/mL
Standard Deviation 21.33
|
|
Vemurafenib Plasma Levels at Various Treatment Cycles
Pre-dose Cycle 4 Day 1, n=109
|
50.31 μg/mL
Standard Deviation 19.52
|
|
Vemurafenib Plasma Levels at Various Treatment Cycles
Pre-dose Cycle 6 Day 1, n=96
|
50.38 μg/mL
Standard Deviation 19.54
|
|
Vemurafenib Plasma Levels at Various Treatment Cycles
Pre-dose Cycle 10 Day 1, n=50
|
50.78 μg/mL
Standard Deviation 20.19
|
|
Vemurafenib Plasma Levels at Various Treatment Cycles
4 hours post-dose Cycle 2 Day 22, n=93
|
48.38 μg/mL
Standard Deviation 20.00
|
|
Vemurafenib Plasma Levels at Various Treatment Cycles
4 hours post-dose Cycle 3 Day 43, n=78
|
50.79 μg/mL
Standard Deviation 19.20
|
|
Vemurafenib Plasma Levels at Various Treatment Cycles
4 hours post-dose Cycle 4 Day 1, n=75
|
55.76 μg/mL
Standard Deviation 20.57
|
|
Vemurafenib Plasma Levels at Various Treatment Cycles
4 hours post-dose Cycle 6 Day 1, n=58
|
58.92 μg/mL
Standard Deviation 20.12
|
|
Vemurafenib Plasma Levels at Various Treatment Cycles
4 hours post-dose Cycle 8 Day 1, n=43
|
58.95 μg/mL
Standard Deviation 20.98
|
|
Vemurafenib Plasma Levels at Various Treatment Cycles
4 hours post-dose Cycle 10 Day 1, n=27
|
63.27 μg/mL
Standard Deviation 21.52
|
SECONDARY outcome
Timeframe: Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1Population: Electrocardiogram (ECG) evaluable population: All treated patients who had a baseline ECG and at least one ECG during treatment.
Three electrocardiograms (ECG) were obtained pre-dose and 2, 4, 6, and 8 hours post-dose at Days 1 and 15 of Cycle 1 and again pre-dose and 4 hours post-dose at various Cycles throughout treatment. Five baseline triplicate ECGs were obtained before the start of treatment at the same time points used during treatment. Reported is the largest mean time-matched QTcP change from baseline. QTcP=QT/(60/heart rate)\^β (β=mean \[calculated separately for males and females\] log-transformed QT versus log-transformed RR regression slopes using all available pre-treatment (baseline) ECG values.
Outcome measures
| Measure |
Vemurafenib 960 mg
n=128 Participants
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)
Cycle 1 Day 15 at 2 hours post-dose, n=109
|
12.8 ms
Interval to 14.9
This is a one-sided confidence interval.
|
|
Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)
Cycle 6 Day 1 at pre-dose, n=85
|
15.1 ms
Interval to 17.7
This is a one-sided confidence interval.
|
SECONDARY outcome
Timeframe: From first treatment through September 27, 2010Population: Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.
The intensity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a 5-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening, and Death).
Outcome measures
| Measure |
Vemurafenib 960 mg
n=132 Participants
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Percentage of Patients With Adverse Event
|
100.0 Percentage of participants
|
Adverse Events
Vemurafenib 960 mg
Serious adverse events
| Measure |
Vemurafenib 960 mg
n=132 participants at risk
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
21.2%
28/132 • Screening through 6 months after the last patient enrolled
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
6.1%
8/132 • Screening through 6 months after the last patient enrolled
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
KERATOACANTHOMA
|
4.5%
6/132 • Screening through 6 months after the last patient enrolled
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
1.5%
2/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
DYSPHAGIA
|
2.3%
3/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.5%
2/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
NAUSEA
|
1.5%
2/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
VOMITING
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Infections and infestations
PNEUMONIA
|
2.3%
3/132 • Screening through 6 months after the last patient enrolled
|
|
Infections and infestations
CELLULITIS
|
1.5%
2/132 • Screening through 6 months after the last patient enrolled
|
|
Infections and infestations
BREAST CELLULITIS
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Infections and infestations
PSEUDOMONAS INFECTION
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Infections and infestations
SALMONELLOSIS
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Infections and infestations
SKIN INFECTION
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Infections and infestations
WOUND INFECTION
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Nervous system disorders
CONVULSION
|
2.3%
3/132 • Screening through 6 months after the last patient enrolled
|
|
Nervous system disorders
FACIAL PALSY
|
2.3%
3/132 • Screening through 6 months after the last patient enrolled
|
|
General disorders
PYREXIA
|
2.3%
3/132 • Screening through 6 months after the last patient enrolled
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
General disorders
PAIN
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.3%
3/132 • Screening through 6 months after the last patient enrolled
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
2.3%
3/132 • Screening through 6 months after the last patient enrolled
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
1.5%
2/132 • Screening through 6 months after the last patient enrolled
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
1.5%
2/132 • Screening through 6 months after the last patient enrolled
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Investigations
BILIRUBIN CONJUGATED INCREASED
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.5%
2/132 • Screening through 6 months after the last patient enrolled
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
1.5%
2/132 • Screening through 6 months after the last patient enrolled
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Cardiac disorders
PERICARDITIS
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Hepatobiliary disorders
HEPATIC CYST
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Hepatobiliary disorders
JAUNDICE
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.5%
2/132 • Screening through 6 months after the last patient enrolled
|
|
Metabolism and nutrition disorders
TUMOUR LYSIS SYNDROME
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
RASH VESICULAR
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Psychiatric disorders
DELIRIUM
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Eye disorders
RETINAL VEIN OCCLUSION
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
|
Respiratory, thoracic and mediastinal disorders
LEFT LUNG GROUND GLASS OPACITIES-PNEUMONITIS
|
0.76%
1/132 • Screening through 6 months after the last patient enrolled
|
Other adverse events
| Measure |
Vemurafenib 960 mg
n=132 participants at risk
Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
|
|---|---|
|
Skin and subcutaneous tissue disorders
RASH
|
51.5%
68/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
49.2%
65/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
35.6%
47/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
30.3%
40/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
SKIN PAPILLOMA
|
29.5%
39/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
HYPERKERATOSIS
|
28.0%
37/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
20.5%
27/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
16.7%
22/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
15.9%
21/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
12.9%
17/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
KERATOSIS PILARIS
|
9.1%
12/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
8.3%
11/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR
|
8.3%
11/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
ERYTHRODYSAESTHESIA SYNDROME ACNE
|
7.6%
10/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
6.8%
9/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
6.1%
8/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
6.1%
8/132 • Screening through 6 months after the last patient enrolled
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
65.2%
86/132 • Screening through 6 months after the last patient enrolled
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
23.5%
31/132 • Screening through 6 months after the last patient enrolled
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
11.4%
15/132 • Screening through 6 months after the last patient enrolled
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.6%
14/132 • Screening through 6 months after the last patient enrolled
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
9.1%
12/132 • Screening through 6 months after the last patient enrolled
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
9.1%
12/132 • Screening through 6 months after the last patient enrolled
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
5.3%
7/132 • Screening through 6 months after the last patient enrolled
|
|
General disorders
FATIGUE
|
53.8%
71/132 • Screening through 6 months after the last patient enrolled
|
|
General disorders
OEDEMA PERIPHERAL
|
22.7%
30/132 • Screening through 6 months after the last patient enrolled
|
|
General disorders
PYREXIA
|
15.2%
20/132 • Screening through 6 months after the last patient enrolled
|
|
General disorders
CHILLS
|
6.8%
9/132 • Screening through 6 months after the last patient enrolled
|
|
General disorders
PAIN
|
5.3%
7/132 • Screening through 6 months after the last patient enrolled
|
|
Eye disorders
VISION BLURRED
|
5.3%
7/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
NAUSEA
|
35.6%
47/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
DIARRHOEA
|
28.0%
37/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
VOMITING
|
25.0%
33/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
CONSTIPATION
|
15.9%
21/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
9.1%
12/132 • Screening through 6 months after the last patient enrolled
|
|
Gastrointestinal disorders
DYSPEPSIA
|
8.3%
11/132 • Screening through 6 months after the last patient enrolled
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
21.2%
28/132 • Screening through 6 months after the last patient enrolled
|
|
Nervous system disorders
HEADACHE
|
27.3%
36/132 • Screening through 6 months after the last patient enrolled
|
|
Nervous system disorders
DYSGEUSIA
|
10.6%
14/132 • Screening through 6 months after the last patient enrolled
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
9.8%
13/132 • Screening through 6 months after the last patient enrolled
|
|
Nervous system disorders
DIZZINESS
|
6.1%
8/132 • Screening through 6 months after the last patient enrolled
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
7.6%
10/132 • Screening through 6 months after the last patient enrolled
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
5.3%
7/132 • Screening through 6 months after the last patient enrolled
|
|
Injury, poisoning and procedural complications
SUNBURN
|
14.4%
19/132 • Screening through 6 months after the last patient enrolled
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
12.1%
16/132 • Screening through 6 months after the last patient enrolled
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
9.8%
13/132 • Screening through 6 months after the last patient enrolled
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
7.6%
10/132 • Screening through 6 months after the last patient enrolled
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
12.9%
17/132 • Screening through 6 months after the last patient enrolled
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
7.6%
10/132 • Screening through 6 months after the last patient enrolled
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
6.1%
8/132 • Screening through 6 months after the last patient enrolled
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.3%
7/132 • Screening through 6 months after the last patient enrolled
|
|
Investigations
BLOOD CREATININE INCREASED
|
9.1%
12/132 • Screening through 6 months after the last patient enrolled
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
5.3%
7/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC KERATOSIS
|
14.4%
19/132 • Screening through 6 months after the last patient enrolled
|
|
Infections and infestations
FOLLICULITIS
|
9.1%
12/132 • Screening through 6 months after the last patient enrolled
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.1%
8/132 • Screening through 6 months after the last patient enrolled
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.3%
7/132 • Screening through 6 months after the last patient enrolled
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
5.3%
7/132 • Screening through 6 months after the last patient enrolled
|
|
Investigations
WEIGHT DECREASED
|
9.1%
12/132 • Screening through 6 months after the last patient enrolled
|
|
Blood and lymphatic system disorders
ANAEMIA
|
8.3%
11/132 • Screening through 6 months after the last patient enrolled
|
|
Psychiatric disorders
DEPRESSION
|
8.3%
11/132 • Screening through 6 months after the last patient enrolled
|
|
Psychiatric disorders
INSOMNIA
|
6.8%
9/132 • Screening through 6 months after the last patient enrolled
|
|
Psychiatric disorders
ANXIETY
|
5.3%
7/132 • Screening through 6 months after the last patient enrolled
|
|
Skin and subcutaneous tissue disorders
ACNE
|
7.6%
10/132 • Screening through 6 months after the last patient enrolled
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
5.3%
7/132 • Screening through 6 months after the last patient enrolled
|
Additional Information
Medical Communications
Hoffmann-La Roche
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