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An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma

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ClinicalTrials.gov Identifier: NCT01136967
Recruitment Status : Completed
First Posted : June 4, 2010
Results First Posted : March 16, 2016
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Unresectable Stage III
Stage IV Melanoma
Intervention Drug: Lenvatinib
Enrollment 182
Recruitment Details A total of 298 participants were screened. Of these, 116 were screen failures and 182 received treatment (93 participants in Cohort 1 and 89 participants in Cohort 2).
Pre-assignment Details  
Arm/Group Title Cohort 1 (V600E BRAF Negative) Cohort 2 (V600E BRAF Positive)
Hide Arm/Group Description Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles. Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Period Title: Overall Study
Started 93 89
Disease Progression 55 56
Treatment Ongoing at Data Cutoff 14 [1] 6 [2]
Completed 69 [3] 62 [4]
Not Completed 24 27
Reason Not Completed
Adverse Event             9             12
Participant Choice             8             3
Lost to Follow-up             0             1
Withdrawal by Subject             1             2
Clinical Progression             3             5
Radiation             1             0
Non Compliance             1             0
Investigator's Choice             1             1
Increase in Lesion Size             0             2
Diagnosis of Second Primary Cancer             0             1
[1]
Entered Extension Phase on treatment at data cut-off (18 January 2012)
[2]
Entered Extension Phase on treatment at data cut-off (15 April 2013)
[3]
Disease Progression and treatment ongoing at data cutoff (18 January 2012)
[4]
Disease Progression and treatment ongoing at data cutoff (15 April 2013)
Arm/Group Title Cohort 1 (V600E BRAF Negative) Cohort 2 (V600E BRAF Positive) Total
Hide Arm/Group Description Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles. Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles. Total of all reporting groups
Overall Number of Baseline Participants 93 89 182
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants 89 participants 182 participants
62.5  (11.71) 55.0  (14.18) 58.8  (13.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 89 participants 182 participants
Female
29
  31.2%
39
  43.8%
68
  37.4%
Male
64
  68.8%
50
  56.2%
114
  62.6%
AJCC Melanoma Tumor, Node, Metastasis (TNM) Stage at Study Entry  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 93 participants 89 participants 182 participants
Unresectable Stage III 5 7 12
Unresectable Stage IV 88 82 170
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants in each cohort who had a best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 for target lesions and assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent radiologic review (IRR). A BOR of CR required confirmation by a subsequent CR assessment at least 4 weeks later. A BOR of PR required confirmation by a subsequent CR or PR assessment at least 4 weeks later. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 millimeters. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
Time Frame From date of first dose of study drug until all participants completed a minimum of 6 cycles (28-day cycles) or discontinued treatment prior to end of Cycle 6 by the date of data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (Intent-to-Treat [ITT] Analysis Set) included all participants who received at least 1 dose study drug.
Arm/Group Title Cohort 1 (V600E BRAF Negative) Cohort 2 (V600E BRAF Positive)
Hide Arm/Group Description:
Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Overall Number of Participants Analyzed 93 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
8.6
(3.8 to 16.2)
9.0
(4.0 to 16.9)
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was measured as the time from the date of first administration of study treatment until the date of first documentation of disease progression or date of death from any cause (whichever occurred first), as determined by IRR and Investigator based on RECIST v1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.
Time Frame From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.
Arm/Group Title Cohort 1 (V600E BRAF Negative) Cohort 2 (V600E BRAF Positive)
Hide Arm/Group Description:
Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Overall Number of Participants Analyzed 93 89
Median (95% Confidence Interval)
Unit of Measure: Months
Determined by IRR
3.7
(2.5 to 4.2)
1.8
(1.8 to 2.2)
Determined by Investigator
3.7
(3.6 to 4.2)
2.3
(1.9 to 3.4)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the length of time in months from the date of first administration of study drug until the date of death from any cause, and was based on the data cutoff date for each cohort.
Time Frame From date of first dose of study drug until date of death from any cause or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.
Arm/Group Title Cohort 1 (V600E BRAF Negative) Cohort 2 (V600E BRAF Positive)
Hide Arm/Group Description:
Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Overall Number of Participants Analyzed 93 89
Median (95% Confidence Interval)
Unit of Measure: Months
8.9 [1] 
(8.3 to NA)
6.3
(5.2 to 8.8)
[1]
NA: Not applicable since the upper limit of the 95% confidence interval was not yet reached at the time of analysis.
4.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description DCR was defined as the percentage of participants who had a BOR of CR or PR or stable disease (SD). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD needed to be greater than or equal to seven weeks based on IRR and Investigator's assessment. DCR = CR + PR + SD
Time Frame From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.
Arm/Group Title Cohort 1 (V600E BRAF Negative) Cohort 2 (V600E BRAF Positive)
Hide Arm/Group Description:
Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Overall Number of Participants Analyzed 93 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Determined by IRR
52.7
(42.1 to 63.1)
34.8
(25.0 to 45.7)
Determined by Investigator
64.5
(53.9 to 74.2)
48.3
(37.6 to 59.2)
5.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description CBR was defined as the percentage of participants who had a BOR of CR or PR or durable SD (SD lasting greater than or equal to 23 weeks) based on IRR and Investigator's assessment. CBR = CR + PR + durable SD rate
Time Frame From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.
Arm/Group Title Cohort 1 (V600E BRAF Negative) Cohort 2 (V600E BRAF Positive)
Hide Arm/Group Description:
Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Overall Number of Participants Analyzed 93 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Determined by IRR
31.2
(22.0 to 41.6)
14.6
(8.0 to 23.7)
Determined by Investigator
33.3
(23.9 to 43.9)
20.2
(12.4 to 30.1)
6.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)/ Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib
Hide Description Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; physical examinations; and regular measurement of vital signs, electrocardiograms (ECGs), and multi-gated acquisition (MUGA) scans or echocardiogram.
Time Frame For each participant, from the first patient first dose till 30 days after the last dose of study drug, up to approximately 2.9 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included those participants who received at least 1 dose of study drug and had at least 1 post baseline safety evaluation.
Arm/Group Title Cohort 1 (V600E BRAF Negative) Cohort 2 (V600E BRAF Positive)
Hide Arm/Group Description:
Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
Overall Number of Participants Analyzed 93 89
Measure Type: Number
Unit of Measure: Participants
AEs 93 89
SAEs 39 36
7.Secondary Outcome
Title Pharmacokinetics and Pharmacodynamics
Hide Description Due to the sparse PK sampling in this study, the data were pooled with data from other Phase 1 studies conducted in participants with solid tumors.
Time Frame Predose and 2 to 12 hours postdose at Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1
Outcome Measure Data Not Reported
Time Frame For each participant, from the first patient first dose till 30 days after the last dose of study drug, up to approximately 2.9 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 (V600E BRAF Negative) Cohort 2 (V600E BRAF Positive)
Hide Arm/Group Description Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles. Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
All-Cause Mortality
Cohort 1 (V600E BRAF Negative) Cohort 2 (V600E BRAF Positive)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 (V600E BRAF Negative) Cohort 2 (V600E BRAF Positive)
Affected / at Risk (%) Affected / at Risk (%)
Total   39/93 (41.94%)   36/89 (40.45%) 
Blood and lymphatic system disorders     
Anaemia  1  0/93 (0.00%)  1/89 (1.12%) 
Cardiac disorders     
Atrial thrombosis  1  1/93 (1.08%)  0/89 (0.00%) 
Cardiac failure congestive  1  1/93 (1.08%)  0/89 (0.00%) 
Supraventricular tachycardia  1  1/93 (1.08%)  0/89 (0.00%) 
Atrioventricular block second degree  1  0/93 (0.00%)  1/89 (1.12%) 
Myocardial infarction  1  0/93 (0.00%)  1/89 (1.12%) 
Pericardial effusion  1  0/93 (0.00%)  1/89 (1.12%) 
Endocrine disorders     
Hypothyroidism  1  0/93 (0.00%)  1/89 (1.12%) 
Gastrointestinal disorders     
Nausea  1  3/93 (3.23%)  3/89 (3.37%) 
Pancreatitis  1  2/93 (2.15%)  0/89 (0.00%) 
Vomiting  1  2/93 (2.15%)  1/89 (1.12%) 
Abdominal pain  1  1/93 (1.08%)  3/89 (3.37%) 
Abdominal pain upper  1  1/93 (1.08%)  0/89 (0.00%) 
Colitis  1  1/93 (1.08%)  0/89 (0.00%) 
Oesophageal spasm  1  1/93 (1.08%)  0/89 (0.00%) 
Rectal perforation  1  1/93 (1.08%)  0/89 (0.00%) 
Constipation  1  0/93 (0.00%)  1/89 (1.12%) 
Diarrhoea  1  0/93 (0.00%)  1/89 (1.12%) 
Enterocolitis  1  0/93 (0.00%)  1/89 (1.12%) 
Intestinal obstruction  1  0/93 (0.00%)  1/89 (1.12%) 
Intestinal perforation  1  0/93 (0.00%)  1/89 (1.12%) 
General disorders     
Pyrexia  1  1/93 (1.08%)  0/89 (0.00%) 
Fatigue  1  0/93 (0.00%)  2/89 (2.25%) 
General physical health deterioration  1  0/93 (0.00%)  2/89 (2.25%) 
Impaired healing  1  0/93 (0.00%)  1/89 (1.12%) 
Pain  1  0/93 (0.00%)  1/89 (1.12%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/93 (1.08%)  0/89 (0.00%) 
Gallbladder perforation  1  1/93 (1.08%)  0/89 (0.00%) 
Cholecystitis  1  0/93 (0.00%)  1/89 (1.12%) 
Cholecystitis acute  1  0/93 (0.00%)  1/89 (1.12%) 
Hepatic failure  1  0/93 (0.00%)  1/89 (1.12%) 
Infections and infestations     
Pneumonia  1  2/93 (2.15%)  2/89 (2.25%) 
Appendicitis  1  1/93 (1.08%)  0/89 (0.00%) 
Catheter site infection  1  1/93 (1.08%)  0/89 (0.00%) 
Incision site infection  1  1/93 (1.08%)  0/89 (0.00%) 
Oral herpes  1  1/93 (1.08%)  0/89 (0.00%) 
Pelvic abscess  1  1/93 (1.08%)  0/89 (0.00%) 
Urinary tract infection  1  1/93 (1.08%)  0/89 (0.00%) 
Cellulitis  1  0/93 (0.00%)  1/89 (1.12%) 
Infection  1  0/93 (0.00%)  1/89 (1.12%) 
Peritonitis  1  0/93 (0.00%)  1/89 (1.12%) 
Sepsis  1  0/93 (0.00%)  1/89 (1.12%) 
Septic shock  1  0/93 (0.00%)  1/89 (1.12%) 
Upper respiratory tract infection  1  0/93 (0.00%)  1/89 (1.12%) 
Wound infection  1  0/93 (0.00%)  1/89 (1.12%) 
Injury, poisoning and procedural complications     
Chemical peritonitis  1  1/93 (1.08%)  0/89 (0.00%) 
Spinal compression fracture  1  0/93 (0.00%)  1/89 (1.12%) 
Investigations     
Ejection fraction decreased  1  1/93 (1.08%)  0/89 (0.00%) 
Lipase increased  1  1/93 (1.08%)  0/89 (0.00%) 
Weight decreased  1  0/93 (0.00%)  1/89 (1.12%) 
Metabolism and nutrition disorders     
Hyponatraemia  1  2/93 (2.15%)  0/89 (0.00%) 
Dehydration  1  1/93 (1.08%)  1/89 (1.12%) 
Failure to thrive  1  0/93 (0.00%)  1/89 (1.12%) 
Hyperuricaemia  1  0/93 (0.00%)  1/89 (1.12%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/93 (1.08%)  0/89 (0.00%) 
Myopathy  1  1/93 (1.08%)  0/89 (0.00%) 
Pain in extremity  1  1/93 (1.08%)  0/89 (0.00%) 
Groin pain  1  0/93 (0.00%)  2/89 (2.25%) 
Musculoskeletal chest pain  1  0/93 (0.00%)  1/89 (1.12%) 
Musculoskeletal pain  1  0/93 (0.00%)  1/89 (1.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Infected neoplasm  1  1/93 (1.08%)  0/89 (0.00%) 
Squamous cell carcinoma of skin  1  1/93 (1.08%)  0/89 (0.00%) 
Tumour pain  1  1/93 (1.08%)  1/89 (1.12%) 
Metastases to central nervous system  1  0/93 (0.00%)  1/89 (1.12%) 
Metastatic pain  1  0/93 (0.00%)  1/89 (1.12%) 
Nervous system disorders     
Cerebrovascular accident  1  2/93 (2.15%)  0/89 (0.00%) 
Hypoaesthesia  1  1/93 (1.08%)  0/89 (0.00%) 
Somnolence  1  1/93 (1.08%)  0/89 (0.00%) 
Syncope  1  1/93 (1.08%)  0/89 (0.00%) 
Cranial nerve palsies multiple  1  0/93 (0.00%)  1/89 (1.12%) 
Haemorrhage intracranial  1  0/93 (0.00%)  1/89 (1.12%) 
Headache  1  0/93 (0.00%)  1/89 (1.12%) 
Presyncope  1  0/93 (0.00%)  1/89 (1.12%) 
Spinal cord compression  1  0/93 (0.00%)  1/89 (1.12%) 
Psychiatric disorders     
Mental status changes  1  2/93 (2.15%)  1/89 (1.12%) 
Confusional state  1  1/93 (1.08%)  0/89 (0.00%) 
Renal and urinary disorders     
Renal failure  1  1/93 (1.08%)  0/89 (0.00%) 
Renal failure acute  1  1/93 (1.08%)  0/89 (0.00%) 
Urethral obstruction  1  1/93 (1.08%)  0/89 (0.00%) 
Urinary retention  1  1/93 (1.08%)  0/89 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  3/93 (3.23%)  2/89 (2.25%) 
Dyspnoea  1  0/93 (0.00%)  1/89 (1.12%) 
Pleural effusion  1  0/93 (0.00%)  1/89 (1.12%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/93 (1.08%)  0/89 (0.00%) 
Dermatitis bullous  1  1/93 (1.08%)  0/89 (0.00%) 
Vascular disorders     
Hypertension  1  5/93 (5.38%)  1/89 (1.12%) 
Deep vein thrombosis  1  3/93 (3.23%)  0/89 (0.00%) 
Aortic aneurysm  1  1/93 (1.08%)  0/89 (0.00%) 
Hypertensive crisis  1  1/93 (1.08%)  1/89 (1.12%) 
Hypotension  1  1/93 (1.08%)  0/89 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 (V600E BRAF Negative) Cohort 2 (V600E BRAF Positive)
Affected / at Risk (%) Affected / at Risk (%)
Total   93/93 (100.00%)   88/89 (98.88%) 
Blood and lymphatic system disorders     
Anaemia  1  5/93 (5.38%)  6/89 (6.74%) 
Thrombocytopenia  1  8/93 (8.60%)  9/89 (10.11%) 
Endocrine disorders     
Hypothyroidism  1  17/93 (18.28%)  24/89 (26.97%) 
Gastrointestinal disorders     
Abdominal pain  1  21/93 (22.58%)  19/89 (21.35%) 
Abdominal pain upper  1  11/93 (11.83%)  6/89 (6.74%) 
Constipation  1  25/93 (26.88%)  28/89 (31.46%) 
Diarrhoea  1  44/93 (47.31%)  26/89 (29.21%) 
Dry mouth  1  14/93 (15.05%)  10/89 (11.24%) 
Dyspepsia  1  5/93 (5.38%)  9/89 (10.11%) 
Flatulence  1  12/93 (12.90%)  2/89 (2.25%) 
Gastrooesophageal reflux disease  1  10/93 (10.75%)  6/89 (6.74%) 
Glossodynia  1  6/93 (6.45%)  2/89 (2.25%) 
Nausea  1  48/93 (51.61%)  36/89 (40.45%) 
Oral pain  1  10/93 (10.75%)  5/89 (5.62%) 
Stomatitis  1  16/93 (17.20%)  12/89 (13.48%) 
Vomiting  1  36/93 (38.71%)  32/89 (35.96%) 
General disorders     
Asthenia  1  6/93 (6.45%)  5/89 (5.62%) 
Chills  1  6/93 (6.45%)  4/89 (4.49%) 
Fatigue  1  62/93 (66.67%)  41/89 (46.07%) 
Oedema peripheral  1  14/93 (15.05%)  10/89 (11.24%) 
Pain  1  6/93 (6.45%)  5/89 (5.62%) 
Pyrexia  1  7/93 (7.53%)  10/89 (11.24%) 
Infections and infestations     
Oral herpes  1  5/93 (5.38%)  0/89 (0.00%) 
Upper respiratory tract infection  1  5/93 (5.38%)  4/89 (4.49%) 
Urinary tract infection  1  10/93 (10.75%)  9/89 (10.11%) 
Investigations     
Aspartate aminotransferase increased  1  3/93 (3.23%)  5/89 (5.62%) 
Blood alkaline phosphatase increased  1  7/93 (7.53%)  3/89 (3.37%) 
Blood thyroid stimulating hormone increased  1  14/93 (15.05%)  7/89 (7.87%) 
Gamma-glutamyltransferase increased  1  5/93 (5.38%)  1/89 (1.12%) 
Lipase increased  1  7/93 (7.53%)  3/89 (3.37%) 
Weight decreased  1  22/93 (23.66%)  12/89 (13.48%) 
Metabolism and nutrition disorders     
Decreased appetite  1  40/93 (43.01%)  30/89 (33.71%) 
Dehydration  1  6/93 (6.45%)  12/89 (13.48%) 
Hypokalaemia  1  6/93 (6.45%)  2/89 (2.25%) 
Hyponatraemia  1  8/93 (8.60%)  4/89 (4.49%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  29/93 (31.18%)  20/89 (22.47%) 
Back pain  1  17/93 (18.28%)  12/89 (13.48%) 
Muscle spasms  1  7/93 (7.53%)  5/89 (5.62%) 
Muscular weakness  1  8/93 (8.60%)  3/89 (3.37%) 
Musculoskeletal chest pain  1  3/93 (3.23%)  6/89 (6.74%) 
Musculoskeletal pain  1  6/93 (6.45%)  6/89 (6.74%) 
Musculoskeletal stiffness  1  7/93 (7.53%)  4/89 (4.49%) 
Myalgia  1  13/93 (13.98%)  9/89 (10.11%) 
Pain in extremity  1  16/93 (17.20%)  9/89 (10.11%) 
Nervous system disorders     
Dizziness  1  10/93 (10.75%)  16/89 (17.98%) 
Dysgeusia  1  12/93 (12.90%)  16/89 (17.98%) 
Headache  1  29/93 (31.18%)  21/89 (23.60%) 
Lethargy  1  1/93 (1.08%)  5/89 (5.62%) 
Peripheral sensory neuropathy  1  10/93 (10.75%)  2/89 (2.25%) 
Psychiatric disorders     
Confusional state  1  2/93 (2.15%)  5/89 (5.62%) 
Depression  1  4/93 (4.30%)  5/89 (5.62%) 
Insomnia  1  7/93 (7.53%)  8/89 (8.99%) 
Renal and urinary disorders     
Haematuria  1  5/93 (5.38%)  3/89 (3.37%) 
Proteinuria  1  23/93 (24.73%)  17/89 (19.10%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  18/93 (19.35%)  11/89 (12.36%) 
Dysphonia  1  26/93 (27.96%)  33/89 (37.08%) 
Dyspnoea  1  14/93 (15.05%)  13/89 (14.61%) 
Epistaxis  1  8/93 (8.60%)  8/89 (8.99%) 
Oropharyngeal pain  1  13/93 (13.98%)  5/89 (5.62%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  16/93 (17.20%)  7/89 (7.87%) 
Pruritus  1  7/93 (7.53%)  5/89 (5.62%) 
Rash  1  16/93 (17.20%)  5/89 (5.62%) 
Vascular disorders     
Hot flush  1  5/93 (5.38%)  1/89 (1.12%) 
Hypertension  1  53/93 (56.99%)  48/89 (53.93%) 
Hypotension  1  4/93 (4.30%)  6/89 (6.74%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.0
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.
 
Results Point of Contact
Name/Title: Eisai Medical Services
Organization: Eisai, Inc.
Phone: 1-888-422-4743
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01136967     History of Changes
Other Study ID Numbers: E7080-G000-206
First Submitted: June 2, 2010
First Posted: June 4, 2010
Results First Submitted: March 13, 2015
Results First Posted: March 16, 2016
Last Update Posted: March 16, 2016