Trial Outcomes & Findings for A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases (NCT NCT01253564)
NCT ID: NCT01253564
Last Updated: 2017-07-31
Results Overview
AE:any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Grade-1:discomfort but no disruption of normal daily activity. Grade-2:discomfort sufficient to reduce or affect daily activity,no intervention indicated.Grade-3:inability to perform normal daily activity,intervention indicated.Grade-4:immediate threat to life or leading to permanent mental or physical condition that prevented performing normal daily activities.Grade 5: death. Any AE included participants with serious and non-serious AE.
COMPLETED
PHASE2
24 participants
From baseline up to last dose (0.1 to 11.3 months) plus 28 days
2017-07-31
Participant Flow
Participant milestones
| Measure |
Vemurafenib
Participants received vemurafenib tablets, 960 milligrams (mg), twice daily (BID), orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Vemurafenib
Participants received vemurafenib tablets, 960 milligrams (mg), twice daily (BID), orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Overall Study
Disease Progression
|
22
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Serious Adverse Event
|
1
|
Baseline Characteristics
A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases
Baseline characteristics by cohort
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 13.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline up to last dose (0.1 to 11.3 months) plus 28 daysPopulation: Safety Population.
AE:any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Grade-1:discomfort but no disruption of normal daily activity. Grade-2:discomfort sufficient to reduce or affect daily activity,no intervention indicated.Grade-3:inability to perform normal daily activity,intervention indicated.Grade-4:immediate threat to life or leading to permanent mental or physical condition that prevented performing normal daily activities.Grade 5: death. Any AE included participants with serious and non-serious AE.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs)
Any AEs
|
96 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Drug-related AEs
|
83 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
AEs of Grade 1 and 2
|
92 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
AEs of Grade 3
|
17 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
AEs of Grade 5
|
4 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
SAEs
|
58 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
Drug-related SAEs
|
17 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
AEs that led to Study Drug Discontinuation
|
4 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
AEs that led to Study Drug Reduction
|
0 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs)
AEs that led to Study Drug Interruption
|
4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)Population: Safety population. Here, 'n' signifies the number of participants with measurable disease at baseline for specified category.
Objective response was assessed by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) (Version 1.1). CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Best overall response was calculated separately for brain, other sites (extracranial) and whole body. Percentage of participants with 95 percent (%) Clopper-Pearson confidence interval (CI) are reported.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site
Brain (n=19)
|
15.8 percentage of participants
Interval 3.4 to 39.6
|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site
Extracranial (n=21)
|
61.9 percentage of participants
Interval 38.4 to 81.9
|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site
Whole body (n=24)
|
41.7 percentage of participants
Interval 22.1 to 63.4
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease or death (up to 16 months)Population: Safety population. Here, 'n' signifies number of participants with best overall response of CR or PR for specified category.
Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease (PD) or death, only for those participants whose best overall response was CR or PR. CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions. Duration of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Duration of Response by Disease Site
Brain (n=3)
|
4.4 months
Interval 2.1 to 4.6
|
|
Duration of Response by Disease Site
Extracranial (n=13)
|
3.8 months
Interval 2.7 to 5.3
|
|
Duration of Response by Disease Site
Whole body (n=10)
|
3.7 months
Interval 2.7 to 4.8
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)Population: Safety population. Here, 'n' signifies number of participants with measurable disease for specified category.
Time to response was defined as the interval between the date of first treatment and the date of first documentation of CR or PR (whichever occurred first). CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Time of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Time to Response by Disease Site
Brain (n=19)
|
NA months
Estimate not available due to insufficient follow-up to allow estimation.
|
|
Time to Response by Disease Site
Extracranial (n=20)
|
1.4 months
Interval 0.9 to
Estimate not available due to insufficient follow-up to allow estimation.
|
|
Time to Response by Disease Site
Whole body (n=23)
|
5.5 months
Interval 1.8 to
Estimate not available due to insufficient follow-up to allow estimation.
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)Population: Safety Population. Here, 'n' signifies number of participants with measurable disease at baseline for specified category.
Duration of SD was defined as the time between the first documented date of SD and date of PD or death from any cause. SD was defined (according to RECIST version 1.1) as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Duration of SD was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Duration of Stable Disease (SD) by Disease Site
Brain (n=13)
|
5.5 months
Interval 4.1 to 5.6
|
|
Duration of Stable Disease (SD) by Disease Site
Extracranial (n=6)
|
3.9 months
Interval 2.3 to 12.1
|
|
Duration of Stable Disease (SD) by Disease Site
Whole body (n=9)
|
3.9 months
Interval 3.7 to 5.6
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)Population: Safety population. Here, 'n' signifies number of participants with measurable disease at baseline for specified category.
Time to new lesions was defined as the interval between the date of first treatment and the date of first documentation of new lesions. Time to new lesion was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Time to New Lesion by Disease Site
Extracranial (n=23)
|
NA months
Estimate not available due to insufficient follow-up to allow estimation.
|
|
Time to New Lesion by Disease Site
Whole body (n=23)
|
5.6 months
Interval 3.9 to
Estimate not available due to insufficient follow-up to allow estimation.
|
|
Time to New Lesion by Disease Site
Brain (n=23)
|
5.6 months
Interval 3.9 to
Estimate not available due to insufficient follow-up to allow estimation.
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)Population: Safety Population.
Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Percentage of participants with disease progression by brain, other sites (extracranial) and whole body are reported.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Percentage of Participants With Disease Progression or Death by Disease Site
Brain
|
100 percentage of participants
|
|
Percentage of Participants With Disease Progression or Death by Disease Site
Extracranial
|
83.3 percentage of participants
|
|
Percentage of Participants With Disease Progression or Death by Disease Site
Whole body
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)Population: Safety Population.
PFS was defined as the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Progression Free Survival (PFS)
Brain
|
4.3 months
Interval 3.1 to 5.5
|
|
Progression Free Survival (PFS)
Extracranial
|
4.6 months
Interval 3.1 to 5.6
|
|
Progression Free Survival (PFS)
Whole body
|
3.9 months
Interval 3.0 to 5.5
|
SECONDARY outcome
Timeframe: Baseline up to end of the study and every 3 months during follow-up (up to 16 months)Population: Safety Population.
Percentage of participants who died due to any reason are reported.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Percentage of Participants Who Died
|
79.2 percentage of participants
|
SECONDARY outcome
Timeframe: From start of treatment up to end of the study and every 3 months during follow up (up to 16 months)Population: Safety population.
OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death. Participants who discontinued the study treatment for any reason other than withdrawal of consent were continued to be followed for survival. The end of study occurred when all participants had been followed for a period of 6 months, had died, withdrawn consent or were lost to follow-up, whichever occurred first. OS was calculated by Kaplan-Meier estimates.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Overall Survival (OS)
|
5.3 months
Interval 3.9 to 6.6
|
SECONDARY outcome
Timeframe: Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 daysPopulation: Safety Population.
An improvement in corticosteroid dose was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely. Percentage of participants and 95% Clopper-Pearson CI are reported.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Percentage of Participants With Improvement in Total Daily Dose of Corticosteroids
|
66.7 percentage of participants
Interval 44.7 to 84.4
|
SECONDARY outcome
Timeframe: Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 daysPopulation: Safety Population
An improvement in narcotic pain analgesics was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Percentage of Participants With Improvement in Total Daily Dose of Narcotic Pain Analgesic
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Day 1 of Cycles 2-8 (28-day cycle) and at the end of study visit (up to 16 months)Population: Safety population. Here, 'n' signifies number of participants with available data for specified category.
VAS is a measure of pain intensity. The participant was asked to mark on a 100 mm line where their pain level was on the day they completed the scale. The beginning of the line represented no pain and the end of the line represented maximum pain. Total score ranged from 0 - 100. Reported values are decrease in VAS of greater than (\>) 20 mm or \>30 mm from baseline.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of > 20 mm: Any visit (n=24)
|
25.0 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of >30 mm: Any visit (n=24)
|
20.8 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of > 20 mm: Cycle 2 - Day 29 (n=23)
|
26.1 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of >30 mm: Cycle 2 - Day 29 (n=23)
|
13.0 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of > 20 mm: Cycle 3 - Day 57 (n=20)
|
20.0 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of >30 mm: Cycle 3 - Day 57 (n=20)
|
20.0 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of > 20 mm: Cycle 4 - Day 85 (n=18)
|
16.7 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of >30 mm: Cycle 4 - Day 85 (n=18)
|
16.7 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of > 20 mm: Cycle 5 - Day 113 (n=13)
|
7.7 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of >30 mm: Cycle 5 - Day 113 (n=13)
|
7.7 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of > 20 mm: Cycle 6 - Day 141 (n=10)
|
10.0 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of > 30 mm: Cycle 6 - Day 141 (n=10)
|
10.0 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of > 20 mm: Cycle 7 - Day 169 (n=8)
|
12.5 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of > 30 mm: Cycle 7 - Day 169 (n=8)
|
0.0 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of > 20 mm: Cycle 8 - Day 197 (n=4)
|
25.0 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of >30 mm: Cycle 8 - Day 197 (n=4)
|
25.0 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of > 20 mm: End of Study (n=12)
|
16.7 percentage of participants
|
|
Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Decrease of >30 mm: End of Study (n=12)
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of every 28-day cycle, at end of study and at the 28-day follow-up visit (up to 16 months)Population: Safety population.
Physician's Assessment of Global Performance Status was assessed on 7 point scale (1- Very much better, 2-Much better, 3-A little better, 4-No change, 5-A little worse, 6-Much worse, 7- Very much worse). An improvement was classed as a difference from baseline of at least -1 point. Percentage of participants with 95% Clopper-Pearson CI were reported for participants with improvement in Physician's Assessment of Global Performance Status at any visit.
Outcome measures
| Measure |
Vemurafenib
n=24 Participants
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Percentage of Participants With Improvement in Physician's Assessment of Global Performance Status
|
83.3 percentage of participants
Interval 58.6 to 96.4
|
Adverse Events
Vemurafenib
Serious adverse events
| Measure |
Vemurafenib
n=24 participants at risk
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
16.7%
4/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Nervous system disorders
Epilepsy
|
20.8%
5/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Nervous system disorders
Cerebral disorder
|
4.2%
1/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Gastrointestinal disorders
Ileus
|
4.2%
1/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
General disorders
Chest discomfort
|
4.2%
1/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Infections and infestations
Erysipelas
|
4.2%
1/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
4.2%
1/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Investigations
C-reactive protein increased
|
4.2%
1/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Psychiatric disorders
Confusional state
|
4.2%
1/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.2%
1/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
Other adverse events
| Measure |
Vemurafenib
n=24 participants at risk
Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
16.7%
4/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.8%
5/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
20.8%
5/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.8%
5/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Nervous system disorders
Dizziness
|
20.8%
5/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Nervous system disorders
Epilepsy
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Nervous system disorders
Paraesthesia
|
20.8%
5/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Nervous system disorders
Dysgeusia
|
12.5%
3/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Nervous system disorders
Ageusia
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.5%
9/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
20.8%
5/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Gastrointestinal disorders
Vomiting
|
20.8%
5/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Gastrointestinal disorders
Diarrhoea
|
20.8%
5/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Gastrointestinal disorders
Constipation
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Infections and infestations
Oral candidiasis
|
16.7%
4/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Infections and infestations
Folliculitis
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Infections and infestations
Oral herpes
|
12.5%
3/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Infections and infestations
Influenza
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
General disorders
Fatigue
|
16.7%
4/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
General disorders
Oedema peripheral
|
16.7%
4/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
12.5%
3/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
12.5%
3/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
3/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Psychiatric disorders
Sleep disorder
|
12.5%
3/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Vascular disorders
Haematoma
|
12.5%
3/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Ear and labyrinth disorders
Hearing impaired
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
2/24 • From baseline up to last dose (0.1 to 11.3 months) plus 28 days
|
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