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A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation

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ClinicalTrials.gov Identifier: NCT01286753
Recruitment Status : Completed
First Posted : January 31, 2011
Results First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms
Intervention Drug: Vemurafenib
Enrollment 51
Recruitment Details  
Pre-assignment Details Written informed consent for participation in the study was obtained before performing any study-specific screening tests or evaluations.
Arm/Group Title Tyrosine Kinase Inhibitor (TKI) Naive TKI Experienced
Hide Arm/Group Description Vemurafenib 960 milligrams (mg) orally twice daily in participants naive to any prior systemic TKI therapy. Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against vascular endothelial growth factor receptor 2 (VEGFR).
Period Title: Overall Study
Started 26 25
Completed 0 0
Not Completed 26 25
Reason Not Completed
Adverse Event             7             6
Progression             11             13
Refused Treatment             1             0
Withdrawal of Consent             0             2
Discontinued to Join Extension Study             6             4
Participant to Receive Radiotherapy             1             0
Arm/Group Title TKI Naive TKI Experienced Total
Hide Arm/Group Description Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy. Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR. Total of all reporting groups
Overall Number of Baseline Participants 26 25 51
Hide Baseline Analysis Population Description
Intent-to-Treat population, defined as all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 25 participants 51 participants
62.9  (13.5) 65.2  (9.1) 64.0  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 51 participants
Female
11
  42.3%
12
  48.0%
23
  45.1%
Male
15
  57.7%
13
  52.0%
28
  54.9%
1.Primary Outcome
Title Best Overall Response Rate in TKI-Naive Participants
Hide Description Best overall response rate was assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Best overall response rate: the percentage of participants with best objective response of complete response (CR) or partial response (PR) (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 millimeters (mm). PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters.
Time Frame Up to approximately 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population (TKI Naive group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.
Arm/Group Title TKI Naive
Hide Arm/Group Description:
Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42.3
(23.35 to 63.08)
2.Secondary Outcome
Title Best Overall Response Rate in TKI-Experienced Participants
Hide Description Best overall response rate was assessed by the investigators according to RECIST v1.1. Best overall response rate: the percentage of participants with best objective response of CR or PR (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters.
Time Frame Up to approximately 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population (TKI Experienced group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.
Arm/Group Title TKI Experienced
Hide Arm/Group Description:
Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
27.3
(10.73 to 50.22)
3.Secondary Outcome
Title Clinical Benefit Rate
Hide Description Clinical benefit rate: the percentage of participants with confirmed CR, PR, or stable disease (SD; maintained for at least 6 months) as assessed by investigators according to RECIST v1.1. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to the baseline sum diameters.
Time Frame Up to approximately 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.
Arm/Group Title TKI Naive TKI Experienced
Hide Arm/Group Description:
Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
Overall Number of Participants Analyzed 26 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.1
(52.21 to 88.43)
54.5
(32.21 to 75.61)
4.Secondary Outcome
Title Duration of Response
Hide Description Duration of response (for participants with confirmed best response CR or PR): the interval between earliest qualifying response and date of progression of disease (PD) or death for any cause, whichever occurred first; participants with no documented progression after CR or PR were censored at the date of last known CR or PR, respectively. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study.
Time Frame From the date of first qualifying response to the date of PD or death for any cause (up to approximately 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.
Arm/Group Title TKI Naive TKI Experienced
Hide Arm/Group Description:
Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
Overall Number of Participants Analyzed 26 22
Median (95% Confidence Interval)
Unit of Measure: months
9.5 [1] 
(5.7 to NA)
7.4 [1] 
(3.7 to NA)
[1]
NA = Not estimable due to an insufficient number of events.
5.Secondary Outcome
Title Progression-Free Survival
Hide Description Progression-free survival: the interval between the day of first treatment and the first documentation of PD or death; participants who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression-free; participants without post baseline tumor assessments were censored at the time of enrollment. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study.
Time Frame From the day of first treatment until the first documented PD or death (up to approximately 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.
Arm/Group Title TKI Naive TKI Experienced
Hide Arm/Group Description:
Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
Overall Number of Participants Analyzed 26 22
Median (95% Confidence Interval)
Unit of Measure: months
18.2
(15.5 to 29.3)
8.9
(5.5 to 27.7)
6.Secondary Outcome
Title Overall Survival
Hide Description Overall survival: the interval between the date of first treatment to the date of death, regardless of the cause of death; participants who were alive at the time of the analysis were censored at the date of the last known alive; participants with no post baseline information were censored at the time of enrollment.
Time Frame From the date of first treatment to the date of death for any cause (up to approximately 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population, defined as all enrolled participants.
Arm/Group Title TKI Naive TKI Experienced
Hide Arm/Group Description:
Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
Overall Number of Participants Analyzed 26 25
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(28.3 to NA)
14.4
(8.2 to 29.1)
[1]
NA = Not estimable due to an insufficient number of events.
7.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame Baseline until 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, defined as enrolled participants who received at least one dose of study treatment.
Arm/Group Title TKI Naive TKI Experienced
Hide Arm/Group Description:
Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
Overall Number of Participants Analyzed 26 25
Measure Type: Number
Unit of Measure: percentage of participants
100 100
8.Secondary Outcome
Title Pharmacokinetics of Vemurafenib: Area Under the Concentration-Time Curve (AUC)
Hide Description AUC is a measure of the drug or biologic concentration in the body following administration.
Time Frame Up to approximately 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected for this outcome.
Arm/Group Title TKI Naive TKI Experienced
Hide Arm/Group Description:
Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline until 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 4 years)
Adverse Event Reporting Description Safety population, defined as enrolled participants who received at least one dose of study treatment.
 
Arm/Group Title TKI Naive TKI Experienced
Hide Arm/Group Description Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy. Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
All-Cause Mortality
TKI Naive TKI Experienced
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
TKI Naive TKI Experienced
Affected / at Risk (%) Affected / at Risk (%)
Total   16/26 (61.54%)   18/25 (72.00%) 
Cardiac disorders     
Atrial fibrillation † 1  1/26 (3.85%)  1/25 (4.00%) 
Angina pectoris † 1  1/26 (3.85%)  0/25 (0.00%) 
Cardiac failure congestive † 1  1/26 (3.85%)  0/25 (0.00%) 
Left ventricular dysfunction † 1  0/26 (0.00%)  1/25 (4.00%) 
Myocardial infarction † 1  0/26 (0.00%)  1/25 (4.00%) 
Endocrine disorders     
Hyperthyroidism † 1  1/26 (3.85%)  0/25 (0.00%) 
Eye disorders     
Uveitis † 1  1/26 (3.85%)  0/25 (0.00%) 
Gastrointestinal disorders     
Dysphagia † 1  1/26 (3.85%)  1/25 (4.00%) 
Anal haemorrhage † 1  0/26 (0.00%)  1/25 (4.00%) 
Food poisoning † 1  1/26 (3.85%)  0/25 (0.00%) 
Large intestinal perforation † 1  1/26 (3.85%)  0/25 (0.00%) 
Nausea † 1  1/26 (3.85%)  0/25 (0.00%) 
Oesophageal haemorrhage † 1  0/26 (0.00%)  1/25 (4.00%) 
Oral lichen planus † 1  1/26 (3.85%)  0/25 (0.00%) 
Rectal haemorrhage † 1  0/26 (0.00%)  1/25 (4.00%) 
General disorders     
Fatigue † 1  1/26 (3.85%)  0/25 (0.00%) 
Gait disturbance † 1  0/26 (0.00%)  1/25 (4.00%) 
Multi-organ failure † 1  0/26 (0.00%)  1/25 (4.00%) 
Pyrexia † 1  1/26 (3.85%)  0/25 (0.00%) 
Hepatobiliary disorders     
Hepatotoxicity † 1  1/26 (3.85%)  0/25 (0.00%) 
Infections and infestations     
Pneumonia † 1  0/26 (0.00%)  2/25 (8.00%) 
Diverticulitis † 1  0/26 (0.00%)  1/25 (4.00%) 
Viral labyrinthitis † 1  0/26 (0.00%)  1/25 (4.00%) 
Injury, poisoning and procedural complications     
Radiation necrosis † 1  1/26 (3.85%)  0/25 (0.00%) 
Metabolism and nutrition disorders     
Dehydration † 1  1/26 (3.85%)  0/25 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  1/26 (3.85%)  0/25 (0.00%) 
Back pain † 1  0/26 (0.00%)  1/25 (4.00%) 
Muscular weakness † 1  0/26 (0.00%)  1/25 (4.00%) 
Musculoskeletal chest pain † 1  0/26 (0.00%)  1/25 (4.00%) 
Pathological fracture † 1  1/26 (3.85%)  0/25 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma of skin † 1  7/26 (26.92%)  5/25 (20.00%) 
Keratoacanthoma † 1  2/26 (7.69%)  3/25 (12.00%) 
Squamous cell carcinoma † 1  2/26 (7.69%)  0/25 (0.00%) 
Adenocarcinoma gastric † 1  0/26 (0.00%)  1/25 (4.00%) 
Malignant melanoma † 1  1/26 (3.85%)  0/25 (0.00%) 
Malignant melanoma in situ † 1  0/26 (0.00%)  1/25 (4.00%) 
Papilloma † 1  1/26 (3.85%)  0/25 (0.00%) 
Tumour pain † 1  0/26 (0.00%)  1/25 (4.00%) 
Nervous system disorders     
Cerebrovascular accident † 1  0/26 (0.00%)  2/25 (8.00%) 
Seizure † 1  0/26 (0.00%)  1/25 (4.00%) 
Renal and urinary disorders     
Renal vein thrombosis † 1  0/26 (0.00%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1  2/26 (7.69%)  2/25 (8.00%) 
Aspiration † 1  0/26 (0.00%)  1/25 (4.00%) 
Dysphonia † 1  1/26 (3.85%)  0/25 (0.00%) 
Larygeal oedema † 1  1/26 (3.85%)  0/25 (0.00%) 
Pleuritic pain † 1  1/26 (3.85%)  0/25 (0.00%) 
Pulmonary haemorrhage † 1  0/26 (0.00%)  1/25 (4.00%) 
Skin and subcutaneous tissue disorders     
Actinic keratosis † 1  0/26 (0.00%)  1/25 (4.00%) 
Skin lesions † 1  0/26 (0.00%)  1/25 (4.00%) 
Vascular disorders     
Hypotension † 1  0/26 (0.00%)  2/25 (8.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TKI Naive TKI Experienced
Affected / at Risk (%) Affected / at Risk (%)
Total   26/26 (100.00%)   24/25 (96.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  9/26 (34.62%)  13/25 (52.00%) 
Leukopenia † 1  3/26 (11.54%)  1/25 (4.00%) 
Lymphopenia † 1  5/26 (19.23%)  5/25 (20.00%) 
Neutropenia † 1  2/26 (7.69%)  0/25 (0.00%) 
Thrombocytopenia † 1  2/26 (7.69%)  0/25 (0.00%) 
Eye disorders     
Cataract † 1  2/26 (7.69%)  0/25 (0.00%) 
Photophobia † 1  3/26 (11.54%)  1/25 (4.00%) 
Scleral discolouration † 1  1/26 (3.85%)  2/25 (8.00%) 
Vision blurred † 1  2/26 (7.69%)  3/25 (12.00%) 
Gastrointestinal disorders     
Abdominal pain † 1  2/26 (7.69%)  1/25 (4.00%) 
Abdominal pain upper † 1  2/26 (7.69%)  0/25 (0.00%) 
Constipation † 1  4/26 (15.38%)  2/25 (8.00%) 
Diarrhoea † 1  12/26 (46.15%)  6/25 (24.00%) 
Dry mouth † 1  3/26 (11.54%)  2/25 (8.00%) 
Dyspepsia † 1  1/26 (3.85%)  2/25 (8.00%) 
Dysphagia † 1  4/26 (15.38%)  3/25 (12.00%) 
Gingival bleeding † 1  2/26 (7.69%)  0/25 (0.00%) 
Leukoplakia oral † 1  2/26 (7.69%)  0/25 (0.00%) 
Nausea † 1  13/26 (50.00%)  7/25 (28.00%) 
Oral disorder † 1  0/26 (0.00%)  2/25 (8.00%) 
Stomatitis † 1  2/26 (7.69%)  3/25 (12.00%) 
Vomiting † 1  6/26 (23.08%)  6/25 (24.00%) 
General disorders     
Asthenia † 1  5/26 (19.23%)  3/25 (12.00%) 
Chills † 1  2/26 (7.69%)  4/25 (16.00%) 
Cyst † 1  5/26 (19.23%)  0/25 (0.00%) 
Fatigue † 1  18/26 (69.23%)  14/25 (56.00%) 
Induration † 1  2/26 (7.69%)  0/25 (0.00%) 
Localised oedema † 1  2/26 (7.69%)  0/25 (0.00%) 
Nodule † 1  3/26 (11.54%)  1/25 (4.00%) 
Oedema peripheral † 1  4/26 (15.38%)  7/25 (28.00%) 
Peripheral swelling † 1  0/26 (0.00%)  3/25 (12.00%) 
Pyrexia † 1  1/26 (3.85%)  6/25 (24.00%) 
Hepatobiliary disorders     
Hyperbilirubinaemia † 1  2/26 (7.69%)  1/25 (4.00%) 
Infections and infestations     
Bronchitis † 1  3/26 (11.54%)  2/25 (8.00%) 
Conjunctivitis † 1  4/26 (15.38%)  1/25 (4.00%) 
Folliculitis † 1  2/26 (7.69%)  1/25 (4.00%) 
Hordeolum † 1  2/26 (7.69%)  0/25 (0.00%) 
Influenza † 1  3/26 (11.54%)  2/25 (8.00%) 
Nasopharyngitis † 1  2/26 (7.69%)  2/25 (8.00%) 
Oral candidiasis † 1  3/26 (11.54%)  2/25 (8.00%) 
Rhinitis † 1  2/26 (7.69%)  1/25 (4.00%) 
Sinusitis † 1  2/26 (7.69%)  0/25 (0.00%) 
Skin infection † 1  1/26 (3.85%)  2/25 (8.00%) 
Upper respiratory tract infection † 1  3/26 (11.54%)  2/25 (8.00%) 
Urinary tract infection † 1  3/26 (11.54%)  4/25 (16.00%) 
Injury, poisoning and procedural complications     
Fall † 1  2/26 (7.69%)  1/25 (4.00%) 
Sunburn † 1  3/26 (11.54%)  4/25 (16.00%) 
Investigations     
Alanine aminotransferase increased † 1  4/26 (15.38%)  5/25 (20.00%) 
Aspartate aminotransferase increased † 1  5/26 (19.23%)  6/25 (24.00%) 
Blood alkaline phosphatase increased † 1  7/26 (26.92%)  6/25 (24.00%) 
Blood bilirubin increased † 1  10/26 (38.46%)  10/25 (40.00%) 
Blood creatinine increased † 1  13/26 (50.00%)  6/25 (24.00%) 
Blood glucose increased † 1  2/26 (7.69%)  0/25 (0.00%) 
Blood pressure increased † 1  0/26 (0.00%)  2/25 (8.00%) 
Blood thyroid stimulating hormone increased † 1  2/26 (7.69%)  1/25 (4.00%) 
Blood uric acid increased † 1  4/26 (15.38%)  2/25 (8.00%) 
Electrocardiogram QT prolonged † 1  4/26 (15.38%)  0/25 (0.00%) 
Gamma-glutamyltransferase increased † 1  7/26 (26.92%)  7/25 (28.00%) 
Haemoglobin decreased † 1  0/26 (0.00%)  2/25 (8.00%) 
Lymphocyte count decreased † 1  2/26 (7.69%)  0/25 (0.00%) 
Platelet count decreased † 1  0/26 (0.00%)  2/25 (8.00%) 
Weight decreased † 1  14/26 (53.85%)  14/25 (56.00%) 
White blood cell count decreased † 1  2/26 (7.69%)  1/25 (4.00%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  13/26 (50.00%)  11/25 (44.00%) 
Dehydration † 1  1/26 (3.85%)  3/25 (12.00%) 
Hypercholesterolaemia † 1  2/26 (7.69%)  0/25 (0.00%) 
Hyperglycaemia † 1  4/26 (15.38%)  5/25 (20.00%) 
Hyperkalaemia † 1  2/26 (7.69%)  2/25 (8.00%) 
Hypoalbuminaemia † 1  2/26 (7.69%)  5/25 (20.00%) 
Hypocalcaemia † 1  5/26 (19.23%)  4/25 (16.00%) 
Hypoglycaemia † 1  0/26 (0.00%)  2/25 (8.00%) 
Hypokalaemia † 1  3/26 (11.54%)  6/25 (24.00%) 
Hypomagnesaemia † 1  1/26 (3.85%)  2/25 (8.00%) 
Hyponatraemia † 1  4/26 (15.38%)  7/25 (28.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  12/26 (46.15%)  9/25 (36.00%) 
Back pain † 1  3/26 (11.54%)  4/25 (16.00%) 
Bursitis † 1  0/26 (0.00%)  2/25 (8.00%) 
Muscle spasms † 1  2/26 (7.69%)  1/25 (4.00%) 
Muscular weakness † 1  1/26 (3.85%)  2/25 (8.00%) 
Musculoskeletal chest pain † 1  0/26 (0.00%)  2/25 (8.00%) 
Musculoskeletal pain † 1  3/26 (11.54%)  5/25 (20.00%) 
Myalgia † 1  9/26 (34.62%)  5/25 (20.00%) 
Neck pain † 1  4/26 (15.38%)  1/25 (4.00%) 
Pain in extremity † 1  4/26 (15.38%)  7/25 (28.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acrochordon † 1  5/26 (19.23%)  1/25 (4.00%) 
Dysplastic naevus † 1  3/26 (11.54%)  3/25 (12.00%) 
Haemangioma † 1  2/26 (7.69%)  1/25 (4.00%) 
Melanocytic naevus † 1  6/26 (23.08%)  3/25 (12.00%) 
Seborrhoeic keratosis † 1  1/26 (3.85%)  2/25 (8.00%) 
Skin papilloma † 1  13/26 (50.00%)  8/25 (32.00%) 
Nervous system disorders     
Dizziness † 1  2/26 (7.69%)  8/25 (32.00%) 
Dysgeusia † 1  14/26 (53.85%)  6/25 (24.00%) 
Headache † 1  7/26 (26.92%)  6/25 (24.00%) 
Paraesthesia † 1  6/26 (23.08%)  1/25 (4.00%) 
Peripheral sensory neuropathy † 1  2/26 (7.69%)  2/25 (8.00%) 
Psychiatric disorders     
Agitation † 1  0/26 (0.00%)  2/25 (8.00%) 
Insomnia † 1  4/26 (15.38%)  3/25 (12.00%) 
Renal and urinary disorders     
Haematuria † 1  2/26 (7.69%)  1/25 (4.00%) 
Micturition urgency † 1  1/26 (3.85%)  2/25 (8.00%) 
Pollakiuria † 1  0/26 (0.00%)  2/25 (8.00%) 
Proteinuria † 1  6/26 (23.08%)  4/25 (16.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  1/26 (3.85%)  5/25 (20.00%) 
Dysphonia † 1  2/26 (7.69%)  1/25 (4.00%) 
Dyspnoea † 1  3/26 (11.54%)  1/25 (4.00%) 
Epistaxis † 1  0/26 (0.00%)  2/25 (8.00%) 
Oropharyngeal pain † 1  1/26 (3.85%)  3/25 (12.00%) 
Productive cough † 1  2/26 (7.69%)  1/25 (4.00%) 
Vocal cord thickening † 1  2/26 (7.69%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders     
Actinic keratosis † 1  7/26 (26.92%)  4/25 (16.00%) 
Alopecia † 1  14/26 (53.85%)  7/25 (28.00%) 
Dermal cyst † 1  4/26 (15.38%)  3/25 (12.00%) 
Dermatitis † 1  1/26 (3.85%)  2/25 (8.00%) 
Dermatitis acneiform † 1  4/26 (15.38%)  2/25 (8.00%) 
Dry skin † 1  6/26 (23.08%)  6/25 (24.00%) 
Erythema † 1  2/26 (7.69%)  5/25 (20.00%) 
Erythema nodosum † 1  2/26 (7.69%)  0/25 (0.00%) 
Hyperkeratosis † 1  11/26 (42.31%)  6/25 (24.00%) 
Keratosis pilaris † 1  4/26 (15.38%)  3/25 (12.00%) 
Macule † 1  2/26 (7.69%)  0/25 (0.00%) 
Milia † 1  2/26 (7.69%)  0/25 (0.00%) 
Nail growth abnormal † 1  2/26 (7.69%)  0/25 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome † 1  8/26 (30.77%)  6/25 (24.00%) 
Panniculitis † 1  2/26 (7.69%)  1/25 (4.00%) 
Papule † 1  2/26 (7.69%)  2/25 (8.00%) 
Photosensitivity reaction † 1  8/26 (30.77%)  6/25 (24.00%) 
Pruritus † 1  2/26 (7.69%)  4/25 (16.00%) 
Rash † 1  11/26 (42.31%)  7/25 (28.00%) 
Rash macular † 1  1/26 (3.85%)  4/25 (16.00%) 
Rash maculo-papular † 1  6/26 (23.08%)  4/25 (16.00%) 
Rash papular † 1  3/26 (11.54%)  1/25 (4.00%) 
Seborrhoeic dermatitis † 1  2/26 (7.69%)  3/25 (12.00%) 
Skin exfoliation † 1  2/26 (7.69%)  2/25 (8.00%) 
Skin hyperpigmentation † 1  2/26 (7.69%)  1/25 (4.00%) 
Skin induration † 1  5/26 (19.23%)  1/25 (4.00%) 
Skin lesion † 1  5/26 (19.23%)  4/25 (16.00%) 
Skin mass † 1  1/26 (3.85%)  2/25 (8.00%) 
Vascular disorders     
Hypertension † 1  6/26 (23.08%)  3/25 (12.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01286753    
Other Study ID Numbers: NO25530
2010-024133-23
First Submitted: January 28, 2011
First Posted: January 31, 2011
Results First Submitted: July 22, 2016
Results First Posted: September 7, 2016
Last Update Posted: September 7, 2016