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Trial record 26 of 157 for:    eribulin

Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01439282
Recruitment Status : Completed
First Posted : September 23, 2011
Results First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Estrogen Receptor Positive Tumor
Breast Cancer
Interventions Drug: eribulin mesylate
Drug: capecitabine
Enrollment 77
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine
Hide Arm/Group Description Eribulin mesylate (1.4 mg/m^2) was injected directly as an intravenous (IV) infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally twice a day (BID) on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner. Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Period Title: Overall Study
Started 67 10
Completed 59 9
Not Completed 8 1
Reason Not Completed
Adverse Event             5             0
Withdrawal by Subject             2             0
Not specified             1             1
Arm/Group Title Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine Total
Hide Arm/Group Description Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner. Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner. Total of all reporting groups
Overall Number of Baseline Participants 67 10 77
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) included all participants who received at least one dose of eribulin mesylate plus capecitabine.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 10 participants 77 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
  68.7%
7
  70.0%
53
  68.8%
>=65 years
21
  31.3%
3
  30.0%
24
  31.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 10 participants 77 participants
Female
67
 100.0%
10
 100.0%
77
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%
Hide Description Relative Dose Intensity (RDI) is defined as the amount of drug administered over a specific time and is expressed as the fraction of that recommended for standard of care. The RDI for each participant was calculated as follows: (1) based on each participant’s body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on the case report form; (3) overall RDI = (Dea/Dep + Dca/Dcp)/2. For each individual participant, the regimen was considered feasible if that participant was able to achieve an RDI of at least 85% of the 4 cycles of eribulin plus capecitabine treatment. Missing doses due to any reason was counted as zero in the RDI calculation.
Time Frame 21-Day Cycle 1 through 21-Day Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of eribulin mesylate plus capecitabine.
Arm/Group Title Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine
Hide Arm/Group Description:
Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Overall Number of Participants Analyzed 67 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
77.6
(67.6 to 100)
90.0
(60.6 to 99.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1080
Comments 1-side P value was obtained
Method 1-sample binomial test
Comments [Not Specified]
2.Secondary Outcome
Title Use of Cold Cap for Alopecia
Hide Description Alopecia (hair loss) is a potential side effect of some chemotherapy agents. Chemotherapeutic drugs are toxic and could potentially harm the hair follicles (wear hair grows from) resulting in the hair falling out. It can occur in small patches on various parts of the body or all over the body and is usually temporary when related to cancer treatment. Cold cap therapy is one form of therapy for alopecia involving hair loss from the scalp. Wearing a cap or head covering with cold packs before, during, or after chemotherapy may help prevent hair loss as the cold narrows the blood vessels in the skin on your head which may lead to less of the drug reaching the hair follicles. Alopecia was one of the most common adverse events (AEs) related to eribulin only.
Time Frame On the day of study drug infusion treatments during Cycles 1 through 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of study treatments and had at least one postbaseline safety assessment.
Arm/Group Title Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine
Hide Arm/Group Description:
Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Overall Number of Participants Analyzed 67 10
Measure Type: Number
Unit of Measure: Participants
Participants with alopecia 52 9
Participants who used a cold cap 3 0
Participants who did not use a cold cap 49 9
3.Secondary Outcome
Title Number of Patients With Adverse Events of 4 Cycles of Eribulin Plus Capecitabine in the Adjuvant Setting
Hide Description

Safety will be assessed by the monitoring and recording all AEs and serious adverse events (SAEs), regular monitoring of hematology and clinical chemistry, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status, regular physician assessments, concomitant medications, medical histories, and physical examinations.

Not posted. Treatment-emergent adverse events (TEAEs) and SAEs will be reported with the AEs and SAEs.

Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame Treatment-emergent adverse events and Serious Adverse Events were collected, and included all Adverse Events with a start date on or after Day 1 through 30 days after last dose of study drugs. Participants were followed for about 1 year 3 months.
Adverse Event Reporting Description TEAEs (any grade) of alopecia and neuropathy were followed until resolution or the start of another treatment whichever occurred first. AEs were graded on a 5-point scale according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
 
Arm/Group Title Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine
Hide Arm/Group Description Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner. Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
All-Cause Mortality
Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   14/67 (20.90%)   1/10 (10.00%) 
Blood and lymphatic system disorders     
Febrile neutropenia  2  1/67 (1.49%)  0/10 (0.00%) 
Leukopenia  2  1/67 (1.49%)  0/10 (0.00%) 
Neutropenia  2  1/67 (1.49%)  0/10 (0.00%) 
Eye disorders     
Macular hole  2  1/67 (1.49%)  0/10 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  2  2/67 (2.99%)  0/10 (0.00%) 
Abdominal pain  2  1/67 (1.49%)  0/10 (0.00%) 
Abdominal pain upper  2  1/67 (1.49%)  0/10 (0.00%) 
Enteritis  2  1/67 (1.49%)  0/10 (0.00%) 
Gastritis  2  1/67 (1.49%)  0/10 (0.00%) 
Nausea  2  1/67 (1.49%)  0/10 (0.00%) 
Vomiting  2  1/67 (1.49%)  0/10 (0.00%) 
Infections and infestations     
Pneumonia  2  1/67 (1.49%)  0/10 (0.00%) 
Investigations     
Alanine aminotransferase increased  2  1/67 (1.49%)  0/10 (0.00%) 
Aspartate aminotransferase increased  2  1/67 (1.49%)  0/10 (0.00%) 
Blood alkaline phosphatase increased  2  1/67 (1.49%)  0/10 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  2  1/67 (1.49%)  0/10 (0.00%) 
Hyperglycaemia  2  1/67 (1.49%)  0/10 (0.00%) 
Hypophosphataemia  2  1/67 (1.49%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  2  1/67 (1.49%)  0/10 (0.00%) 
Psychiatric disorders     
Mental status changes  2  1/67 (1.49%)  0/10 (0.00%) 
Anxiety  2  0/67 (0.00%)  1/10 (10.00%) 
Renal and urinary disorders     
Renal failure acute  2  1/67 (1.49%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  3/67 (4.48%)  0/10 (0.00%) 
Pneumonia aspiration  2  1/67 (1.49%)  0/10 (0.00%) 
Vascular disorders     
Deep vein thrombosis  2  1/67 (1.49%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
2
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   67/67 (100.00%)   10/10 (100.00%) 
Blood and lymphatic system disorders     
Neutropenia  1  24/67 (35.82%)  2/10 (20.00%) 
Anaemia  2  6/67 (8.96%)  0/10 (0.00%) 
Leukopenia  2  5/67 (7.46%)  0/10 (0.00%) 
Febrile neutropenia  2  2/67 (2.99%)  0/10 (0.00%) 
Cardiac disorders     
Palpitations  2  2/67 (2.99%)  0/10 (0.00%) 
Angina pectoris  2  1/67 (1.49%)  0/10 (0.00%) 
Electrocardiogram QT prolonged  2  1/67 (1.49%)  0/10 (0.00%) 
Tachycardia  2  1/67 (1.49%)  0/10 (0.00%) 
Ear and labyrinth disorders     
Vertigo  2  1/67 (1.49%)  0/10 (0.00%) 
Endocrine disorders     
Hypothyroidism  2  1/67 (1.49%)  0/10 (0.00%) 
Eye disorders     
Lacrimation increased  2  9/67 (13.43%)  0/10 (0.00%) 
Dry eye  1  2/67 (2.99%)  1/10 (10.00%) 
Vision blurred  2  2/67 (2.99%)  0/10 (0.00%) 
Blepharospasm  2  1/67 (1.49%)  0/10 (0.00%) 
Eye irritation  2  1/67 (1.49%)  0/10 (0.00%) 
Eye pain  2  1/67 (1.49%)  0/10 (0.00%) 
Macular hole  2  1/67 (1.49%)  0/10 (0.00%) 
Visual impairment  2  1/67 (1.49%)  0/10 (0.00%) 
Gastrointestinal disorders     
Nausea  2  35/67 (52.24%)  4/10 (40.00%) 
Diarrhoea  2  27/67 (40.30%)  2/10 (20.00%) 
Constipation  2  23/67 (34.33%)  2/10 (20.00%) 
Vomiting  2  15/67 (22.39%)  0/10 (0.00%) 
Dyspepsia  2  10/67 (14.93%)  3/10 (30.00%) 
Gastrooesophageal reflux disease  2  9/67 (13.43%)  1/10 (10.00%) 
Stomatitis  2  9/67 (13.43%)  1/10 (10.00%) 
Abdominal pain  2  8/67 (11.94%)  2/10 (20.00%) 
Dry mouth  2  8/67 (11.94%)  0/10 (0.00%) 
Haemorrhoids  2  4/67 (5.97%)  0/10 (0.00%) 
Abdominal pain upper  1  2/67 (2.99%)  0/10 (0.00%) 
Gingival pain  1  2/67 (2.99%)  0/10 (0.00%) 
Haemorrhoidal haemorrhage  2  2/67 (2.99%)  0/10 (0.00%) 
Rectal haemorrhage  2  2/67 (2.99%)  0/10 (0.00%) 
Anal fissure  2  1/67 (1.49%)  0/10 (0.00%) 
Anal pruritus  2  1/67 (1.49%)  0/10 (0.00%) 
Chapped lips  2  1/67 (1.49%)  0/10 (0.00%) 
Dysphagia  2  1/67 (1.49%)  0/10 (0.00%) 
Enteritis  2  1/67 (1.49%)  0/10 (0.00%) 
Flatulence  2  1/67 (1.49%)  0/10 (0.00%) 
Gastritis  2  1/67 (1.49%)  0/10 (0.00%) 
Gastrointestinal pain  1  1/67 (1.49%)  0/10 (0.00%) 
Haematochezia  2  1/67 (1.49%)  0/10 (0.00%) 
Lip blister  2  1/67 (1.49%)  0/10 (0.00%) 
Lip dry  2  1/67 (1.49%)  0/10 (0.00%) 
Mouth ulceration  2  1/67 (1.49%)  0/10 (0.00%) 
Oral discomfort  2  1/67 (1.49%)  0/10 (0.00%) 
Oral disorder  2  1/67 (1.49%)  0/10 (0.00%) 
Oral pain  2  1/67 (1.49%)  0/10 (0.00%) 
Retching  2  1/67 (1.49%)  0/10 (0.00%) 
Salivary hypersecretion  2  1/67 (1.49%)  0/10 (0.00%) 
Swollen tongue  2  1/67 (1.49%)  0/10 (0.00%) 
Tongue coated  2  1/67 (1.49%)  0/10 (0.00%) 
Abdominal distension  2  3/67 (4.48%)  0/10 (0.00%) 
General disorders     
Fatigue  2  39/67 (58.21%)  6/10 (60.00%) 
Oedema peripheral  2  10/67 (14.93%)  1/10 (10.00%) 
Pyrexia  2  10/67 (14.93%)  1/10 (10.00%) 
Mucosal inflammation  2  8/67 (11.94%)  2/10 (20.00%) 
Pain  2  5/67 (7.46%)  0/10 (0.00%) 
Asthenia  2  6/67 (8.96%)  0/10 (0.00%) 
Chest pain  2  1/67 (1.49%)  1/10 (10.00%) 
Chills  2  3/67 (4.48%)  1/10 (10.00%) 
Local swelling  2  0/67 (0.00%)  1/10 (10.00%) 
Non-cardiac chest pain  2  2/67 (2.99%)  1/10 (10.00%) 
Early satiety  2  1/67 (1.49%)  0/10 (0.00%) 
Energy increased  2  1/67 (1.49%)  0/10 (0.00%) 
Injection site pain  2  1/67 (1.49%)  0/10 (0.00%) 
Suprapubic pain  2  1/67 (1.49%)  0/10 (0.00%) 
Tenderness  2  1/67 (1.49%)  0/10 (0.00%) 
Immune system disorders     
Drug hypersensitivity  2  1/67 (1.49%)  0/10 (0.00%) 
Seasonal allergy  2  1/67 (1.49%)  0/10 (0.00%) 
Infections and infestations     
Urinary tract infection  2  6/67 (8.96%)  1/10 (10.00%) 
Candida infection  2  0/67 (0.00%)  2/10 (20.00%) 
Upper respiratory tract infection  2  2/67 (2.99%)  1/10 (10.00%) 
Candidiasis  2  3/67 (4.48%)  0/10 (0.00%) 
Nasopharyngitis  2  3/67 (4.48%)  0/10 (0.00%) 
Localised infection  2  2/67 (2.99%)  0/10 (0.00%) 
Oral herpes  2  2/67 (2.99%)  0/10 (0.00%) 
Vaginal infection  2  2/67 (2.99%)  0/10 (0.00%) 
Bronchitis  2  1/67 (1.49%)  0/10 (0.00%) 
Catheter site infection  2  1/67 (1.49%)  0/10 (0.00%) 
Cellulitis  2  1/67 (1.49%)  0/10 (0.00%) 
Labyrinthitis  2  1/67 (1.49%)  0/10 (0.00%) 
Onychomycosis  2  1/67 (1.49%)  0/10 (0.00%) 
Oral fungal infection  1  1/67 (1.49%)  0/10 (0.00%) 
Oral infection  1  1/67 (1.49%)  0/10 (0.00%) 
Paronychia  2  1/67 (1.49%)  0/10 (0.00%) 
Pharyngitis streptococcal  2  1/67 (1.49%)  0/10 (0.00%) 
Pneumonia  2  1/67 (1.49%)  0/10 (0.00%) 
Post procedural infection  2  1/67 (1.49%)  0/10 (0.00%) 
Purulence  2  1/67 (1.49%)  0/10 (0.00%) 
Purulent discharge  2  1/67 (1.49%)  0/10 (0.00%) 
Sinusitis  2  1/67 (1.49%)  0/10 (0.00%) 
Skin infection  2  1/67 (1.49%)  0/10 (0.00%) 
Injury, poisoning and procedural complications     
Infusion related reaction  2  0/67 (0.00%)  1/10 (10.00%) 
Contusion  2  1/67 (1.49%)  0/10 (0.00%) 
Procedural pain  2  1/67 (1.49%)  0/10 (0.00%) 
Investigations     
Aspartate aminotransferase increased  2  10/67 (14.93%)  1/10 (10.00%) 
Alanine aminotransferase increased  2  9/67 (13.43%)  1/10 (10.00%) 
Blood bilirubin increased  2  5/67 (7.46%)  0/10 (0.00%) 
Blood magnesium decreased  2  0/67 (0.00%)  1/10 (10.00%) 
Blood pressure increased  2  0/67 (0.00%)  1/10 (10.00%) 
Liver function test abnormal  2  0/67 (0.00%)  1/10 (10.00%) 
Blood alkaline phosphatase increased  2  3/67 (4.48%)  0/10 (0.00%) 
Weight decreased  2  3/67 (4.48%)  0/10 (0.00%) 
Blood chloride decreased  2  1/67 (1.49%)  0/10 (0.00%) 
Blood lactate dehydrogenase increased  2  1/67 (1.49%)  0/10 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycaemia  2  11/67 (16.42%)  0/10 (0.00%) 
Dehydration  2  10/67 (14.93%)  0/10 (0.00%) 
Hypokalaemia  2  8/67 (11.94%)  0/10 (0.00%) 
Decreased appetite  2  7/67 (10.45%)  3/10 (30.00%) 
Hyponatraemia  2  4/67 (5.97%)  1/10 (10.00%) 
Hypomagnesaemia  2  3/67 (4.48%)  0/10 (0.00%) 
Hypocalcaemia  2  2/67 (2.99%)  0/10 (0.00%) 
Hypophosphataemia  2  2/67 (2.99%)  0/10 (0.00%) 
Appetite disorder  2  1/67 (1.49%)  0/10 (0.00%) 
Diabetes mellitus  2  1/67 (1.49%)  0/10 (0.00%) 
Hypovolaemia  2  1/67 (1.49%)  0/10 (0.00%) 
Increased appetite  2  1/67 (1.49%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  2  8/67 (11.94%)  1/10 (10.00%) 
Pain in extremity  2  6/67 (8.96%)  0/10 (0.00%) 
Back pain  2  2/67 (2.99%)  1/10 (10.00%) 
Bone pain  2  2/67 (2.99%)  1/10 (10.00%) 
Muscle spasms  2  2/67 (2.99%)  1/10 (10.00%) 
Musculoskeletal pain  2  1/67 (1.49%)  1/10 (10.00%) 
Muscular weakness  2  3/67 (4.48%)  0/10 (0.00%) 
Musculoskeletal chest pain  2  2/67 (2.99%)  0/10 (0.00%) 
Myalgia  2  2/67 (2.99%)  0/10 (0.00%) 
Pain in jaw  2  2/67 (2.99%)  0/10 (0.00%) 
Foot deformity  2  1/67 (1.49%)  0/10 (0.00%) 
Joint swelling  2  1/67 (1.49%)  0/10 (0.00%) 
Nervous system disorders     
Headache  2  19/67 (28.36%)  4/10 (40.00%) 
Neuropathy peripheral  2  16/67 (23.88%)  3/10 (30.00%) 
Dysgeusia  2  8/67 (11.94%)  2/10 (20.00%) 
Dizziness  2  5/67 (7.46%)  2/10 (20.00%) 
Hypoaesthesia  2  5/67 (7.46%)  1/10 (10.00%) 
Peripheral sensory neuropathy  2  4/67 (5.97%)  0/10 (0.00%) 
Dysaesthesia  2  0/67 (0.00%)  1/10 (10.00%) 
Paraesthesia  2  3/67 (4.48%)  0/10 (0.00%) 
Burning sensation  2  2/67 (2.99%)  0/10 (0.00%) 
Tremor  2  2/67 (2.99%)  0/10 (0.00%) 
Ageusia  2  1/67 (1.49%)  0/10 (0.00%) 
Lethargy  2  1/67 (1.49%)  0/10 (0.00%) 
Peripheral motor neuropathy  2  1/67 (1.49%)  0/10 (0.00%) 
Sinus headache  2  1/67 (1.49%)  0/10 (0.00%) 
Psychiatric disorders     
Insomnia  2  12/67 (17.91%)  0/10 (0.00%) 
Anxiety  2  7/67 (10.45%)  1/10 (10.00%) 
Depression  1  3/67 (4.48%)  0/10 (0.00%) 
Stress  2  2/67 (2.99%)  0/10 (0.00%) 
Mental status changes  2  1/67 (1.49%)  0/10 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  2  1/67 (1.49%)  0/10 (0.00%) 
Renal failure acute  1  1/67 (1.49%)  0/10 (0.00%) 
Reproductive system and breast disorders     
Vaginal haemorrhage  2  1/67 (1.49%)  0/10 (0.00%) 
Vulval ulceration  2  1/67 (1.49%)  0/10 (0.00%) 
Vulvovaginal dryness  2  1/67 (1.49%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  2  10/67 (14.93%)  2/10 (20.00%) 
Dyspnoea  1  10/67 (14.93%)  1/10 (10.00%) 
Oropharyngeal pain  2  8/67 (11.94%)  0/10 (0.00%) 
Paranasal sinus hypersecretion  2  0/67 (0.00%)  1/10 (10.00%) 
Epistaxis  2  3/67 (4.48%)  0/10 (0.00%) 
Nasal congestion  2  3/67 (4.48%)  0/10 (0.00%) 
Pulmonary embolism  2  3/67 (4.48%)  0/10 (0.00%) 
Dysphonia  2  2/67 (2.99%)  0/10 (0.00%) 
Rhinorrhoea  2  2/67 (2.99%)  0/10 (0.00%) 
Hiccups  2  1/67 (1.49%)  0/10 (0.00%) 
Painful respiration  2  1/67 (1.49%)  0/10 (0.00%) 
Pharyngeal oedema  2  1/67 (1.49%)  0/10 (0.00%) 
Pleuritic pain  2  1/67 (1.49%)  0/10 (0.00%) 
Pneumonia aspiration  2  1/67 (1.49%)  0/10 (0.00%) 
Respiratory tract congestion  2  1/67 (1.49%)  0/10 (0.00%) 
Rhinitis allergic  2  1/67 (1.49%)  0/10 (0.00%) 
Sinus congestion  2  1/67 (1.49%)  0/10 (0.00%) 
Sneezing  2  1/67 (1.49%)  0/10 (0.00%) 
Throat irritation  2  1/67 (1.49%)  0/10 (0.00%) 
Upper-airway cough syndrome  2  1/67 (1.49%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  2  52/67 (77.61%)  9/10 (90.00%) 
Palmar-plantar erythrodysaesthesia syndrome  2  27/67 (40.30%)  2/10 (20.00%) 
Erythema  2  6/67 (8.96%)  0/10 (0.00%) 
Rash  2  6/67 (8.96%)  1/10 (10.00%) 
Skin hyperpigmentation  2  4/67 (5.97%)  1/10 (10.00%) 
Dry skin  2  2/67 (2.99%)  1/10 (10.00%) 
Palmar erythema  2  0/67 (0.00%)  1/10 (10.00%) 
Urticaria  2  1/67 (1.49%)  1/10 (10.00%) 
Blister  2  3/67 (4.48%)  0/10 (0.00%) 
Nail disorder  2  2/67 (2.99%)  0/10 (0.00%) 
Skin exfoliation  2  2/67 (2.99%)  0/10 (0.00%) 
Skin ulcer  2  2/67 (2.99%)  0/10 (0.00%) 
Dermatitis exfoliative  2  1/67 (1.49%)  0/10 (0.00%) 
Hyperhidrosis  2  1/67 (1.49%)  0/10 (0.00%) 
Madarosis  2  1/67 (1.49%)  0/10 (0.00%) 
Nail pigmentation  2  1/67 (1.49%)  0/10 (0.00%) 
Nail ridging  2  1/67 (1.49%)  0/10 (0.00%) 
Night sweats  2  1/67 (1.49%)  0/10 (0.00%) 
Palmoplantar keratoderma  2  1/67 (1.49%)  0/10 (0.00%) 
Pigmentation disorder  2  1/67 (1.49%)  0/10 (0.00%) 
Pruritus  2  1/67 (1.49%)  0/10 (0.00%) 
Rash maculo-papular  2  1/67 (1.49%)  0/10 (0.00%) 
Rash pruritic  2  1/67 (1.49%)  0/10 (0.00%) 
Skin discolouration  2  1/67 (1.49%)  0/10 (0.00%) 
Skin fissures  2  1/67 (1.49%)  0/10 (0.00%) 
Skin mass  2  1/67 (1.49%)  0/10 (0.00%) 
Vascular disorders     
Deep vein thrombosis  2  4/67 (5.97%)  0/10 (0.00%) 
Hot flush  2  3/67 (4.48%)  0/10 (0.00%) 
Hypotension  2  3/67 (4.48%)  0/10 (0.00%) 
Thrombophlebitis superficial  1  2/67 (2.99%)  0/10 (0.00%) 
Flushing  2  1/67 (1.49%)  0/10 (0.00%) 
Hypertension  2  1/67 (1.49%)  0/10 (0.00%) 
Lymphoedema  2  1/67 (1.49%)  0/10 (0.00%) 
Phlebitis superficial  2  1/67 (1.49%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
2
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: NCT01439282     History of Changes
Other Study ID Numbers: E7389-A001-212
First Submitted: September 19, 2011
First Posted: September 23, 2011
Results First Submitted: May 11, 2016
Results First Posted: June 20, 2016
Last Update Posted: June 20, 2016