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Trial record 43 of 157 for:    eribulin

Eribulin Mesylate Phase IV Clinical Trial in Korean Patients With Metastatic or Locally Advanced Breast Cancer (ESKIMO)

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: NCT01961544
Recruitment Status : Completed
First Posted : October 11, 2013
Results First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Neoplasms
Breast Cancer
Intervention Drug: Eribulin mesylate
Enrollment 101
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2
Hide Arm/Group Description Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
Period Title: Overall Study
Started 101
Completed 88
Not Completed 13
Reason Not Completed
Protocol Violation             1
Withdrawal by Subject             7
Adverse Event             1
Physician Decision             2
Poor Tolerance             1
Aggravation of Steral Pain             1
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2
Hide Arm/Group Description Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
Overall Number of Baseline Participants 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Geometric Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
50.36  (10.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Female
101
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE)
Hide Description An AE is defined as any harmful, untoward sign (including abnormal laboratory value, etc.), symptom, or disease in a participant administered investigational product that does not necessarily have a causal relationship with treatment. An SAE is defined as an AE that is life threatening or results in death, results in hospitalization (initial or prolonged), results in a disability (significant, persistent, or permanent change, impairment, damage or disruption in the participant's body function/structure, physical activities, or quality of life), results in a congenital anomaly, or requires intervention to prevent permanent impairment or damage. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.
Time Frame mean of 3.76 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set: all participants who are administered investigational product at least once for the analysis
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2
Hide Arm/Group Description:
Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
Overall Number of Participants Analyzed 101
Measure Type: Number
Unit of Measure: Participants
TEAE 101
Treatment-emergent SAE 20
2.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description DCR is defined as the number of participants with complete response (CR), partial response (PR), and stable disease (SD). The Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to assess the tumor response. Tumor response was evaluated by investigators. CR is defined as the disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 millimeters (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]. The SLD must also demonstrate an absolute increase of at least 5 mm. [Two lesions increasing from 2 mm to 3 mm, for example, does not qualify]).
Time Frame mean of 3.76 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were administered investigational product at least once after enrollment and had at least one primary efficacy data value since Baseline
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2
Hide Arm/Group Description:
Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
Overall Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: Participants
CR 1
PR 15
SD 33
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eribulin Mesylate 1.4 mg/m^2
Hide Arm/Group Description Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2-5 minutes on Day 1 and Day 8 of each 21-day cycle.
All-Cause Mortality
Eribulin Mesylate 1.4 mg/m^2
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eribulin Mesylate 1.4 mg/m^2
Affected / at Risk (%)
Total   20/101 (19.80%) 
Blood and lymphatic system disorders   
Neutropenia * 1  2/101 (1.98%) 
Febrile neutropenia * 1  1/101 (0.99%) 
Cardiac disorders   
Pericardial effusion * 1  2/101 (1.98%) 
Gastrointestinal disorders   
Abdominal distension * 1  1/101 (0.99%) 
Abdominal pain * 1  1/101 (0.99%) 
Ascites * 1  1/101 (0.99%) 
Gastritis * 1  1/101 (0.99%) 
General disorders   
Asthenia * 1  1/101 (0.99%) 
Pyrexia * 1  1/101 (0.99%) 
Infections and infestations   
Pneumonia * 1  1/101 (0.99%) 
Pseudomonal sepsis * 1  1/101 (0.99%) 
Septic shock * 1  1/101 (0.99%) 
Subcutaneous abscess * 1  1/101 (0.99%) 
Injury, poisoning and procedural complications   
Wound secretion * 1  1/101 (0.99%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  1/101 (0.99%) 
Hypophagia * 1  1/101 (0.99%) 
Musculoskeletal and connective tissue disorders   
Pathological fracture * 1  1/101 (0.99%) 
Spinal pain * 1  1/101 (0.99%) 
Nervous system disorders   
Consciousness fluctuating * 1  1/101 (0.99%) 
Dizziness * 1  1/101 (0.99%) 
Headache * 1  1/101 (0.99%) 
Neuropathy peripheral * 1  1/101 (0.99%) 
Syncope * 1  1/101 (0.99%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion * 1  1/101 (0.99%) 
Pneumonia aspiration * 1  1/101 (0.99%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Select
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eribulin Mesylate 1.4 mg/m^2
Affected / at Risk (%)
Total   101/101 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia * 1  92/101 (91.09%) 
Anaemia * 1  12/101 (11.88%) 
Leukopenia * 2  11/101 (10.89%) 
Thrombocytopenia * 2  4/101 (3.96%) 
Febrile neutropenia * 2  1/101 (0.99%) 
Cardiac disorders   
Palpitations * 2  1/101 (0.99%) 
Ear and labyrinth disorders   
Ear pain * 2  1/101 (0.99%) 
External ear pain * 2  1/101 (0.99%) 
Tinnitus * 2  1/101 (0.99%) 
Eye disorders   
Eye pain * 2  4/101 (3.96%) 
Blepharitis * 2  1/101 (0.99%) 
Dry age-related macular degeneration * 2  1/101 (0.99%) 
Dry eye * 2  1/101 (0.99%) 
Vision blurred * 2  1/101 (0.99%) 
Xerophthalmia * 2  1/101 (0.99%) 
Gastrointestinal disorders   
Nausea * 1  25/101 (24.75%) 
Vomiting * 2  11/101 (10.89%) 
Diarrhoea * 2  10/101 (9.90%) 
Dyspepsia * 2  10/101 (9.90%) 
Constipation * 2  9/101 (8.91%) 
Stomatitis * 2  8/101 (7.92%) 
Abdominal pain * 2  5/101 (4.95%) 
Abdominal pain upper * 2  5/101 (4.95%) 
Toothache * 2  3/101 (2.97%) 
Abdominal discomfort * 2  2/101 (1.98%) 
Abdominal distension * 2  2/101 (1.98%) 
Gastrointestinal disorder * 2  2/101 (1.98%) 
Dry mouth * 2  1/101 (0.99%) 
Epigastric discomfort * 2  1/101 (0.99%) 
Food poisoning * 2  1/101 (0.99%) 
Gastritis * 2  1/101 (0.99%) 
Gastrointestinal pain * 2  1/101 (0.99%) 
Gastrooesophageal reflux disease * 2  1/101 (0.99%) 
Gingival bleeding * 2  1/101 (0.99%) 
Mouth ulceration * 2  1/101 (0.99%) 
General disorders   
Fatigue * 2  27/101 (26.73%) 
Pyrexia * 2  17/101 (16.83%) 
Chest pain * 2  10/101 (9.90%) 
Asthenia * 2  8/101 (7.92%) 
Mucosal inflammation * 2  8/101 (7.92%) 
Pain * 2  7/101 (6.93%) 
Chills * 2  5/101 (4.95%) 
Influenza like illness * 2  4/101 (3.96%) 
Oedema peripheral * 2  2/101 (1.98%) 
Peripheral swelling * 2  2/101 (1.98%) 
Application site pain * 2  1/101 (0.99%) 
Face oedema * 2  1/101 (0.99%) 
Localised oedema * 2  1/101 (0.99%) 
Non-cardiac chest pain * 2  1/101 (0.99%) 
Oedema * 2  1/101 (0.99%) 
Infections and infestations   
Nasopharyngitis * 2  7/101 (6.93%) 
Upper respiratory tract infection * 2  6/101 (5.94%) 
Urinary tract infection * 2  3/101 (2.97%) 
Cystitis * 2  2/101 (1.98%) 
Herpes zoster * 2  2/101 (1.98%) 
Pneumonia * 2  2/101 (1.98%) 
Device related infection * 2  1/101 (0.99%) 
Infection * 2  1/101 (0.99%) 
Paronychia * 2  1/101 (0.99%) 
Pyuria * 2  1/101 (0.99%) 
Injury, poisoning and procedural complications   
Eye injury * 2  1/101 (0.99%) 
Investigations   
Aspartate aminotransferase increased * 2  8/101 (7.92%) 
Alanine aminotransferase increased * 2  5/101 (4.95%) 
Electrocardiogram QT prolonged * 2  2/101 (1.98%) 
Haemoglobin decreased * 2  1/101 (0.99%) 
Blood creatinine increased * 2  1/101 (0.99%) 
Neutrophil count increased * 2  1/101 (0.99%) 
Weight decreased * 2  1/101 (0.99%) 
White blood cell count increased * 2  1/101 (0.99%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  41/101 (40.59%) 
Hyperglycaemia * 2  4/101 (3.96%) 
Hypoglycaemia * 2  1/101 (0.99%) 
Hypercalcaemia * 2  1/101 (0.99%) 
Hypoalbuminaemia * 2  1/101 (0.99%) 
Hypokalaemia * 2  1/101 (0.99%) 
Hypomagnesaemia * 2  1/101 (0.99%) 
Musculoskeletal and connective tissue disorders   
Myalgia * 1  25/101 (24.75%) 
Back pain * 2  6/101 (5.94%) 
Pain in extremity * 2  4/101 (3.96%) 
Flank pain * 2  4/101 (3.96%) 
Muscular weakness * 2  3/101 (2.97%) 
Musculoskeletal pain * 2  2/101 (1.98%) 
Arthralgia * 2  1/101 (0.99%) 
Arthritis * 2  1/101 (0.99%) 
Bone pain * 2  1/101 (0.99%) 
Musculoskeletal chest pain * 2  1/101 (0.99%) 
Musculoskeletal discomfort * 2  1/101 (0.99%) 
Neck pain * 2  1/101 (0.99%) 
Osteonecrosis of jaw * 2  1/101 (0.99%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour haemorrhage * 2  1/101 (0.99%) 
Nervous system disorders   
Peripheral sensory neuropathy * 2  16/101 (15.84%) 
Headache * 2  12/101 (11.88%) 
Neuropathy peripheral * 2  11/101 (10.89%) 
Dizziness * 2  7/101 (6.93%) 
Lethargy * 2  4/101 (3.96%) 
Hypoaesthesia * 2  3/101 (2.97%) 
Paraesthesia * 2  2/101 (1.98%) 
Dysgeusia * 2  1/101 (0.99%) 
Hemiparesis * 2  1/101 (0.99%) 
Peripheral motor neuropathy * 2  1/101 (0.99%) 
Psychiatric disorders   
Insomnia * 1  8/101 (7.92%) 
Depression * 2  3/101 (2.97%) 
Anxiety * 2  2/101 (1.98%) 
Eating disorder symptom * 2  1/101 (0.99%) 
Renal and urinary disorders   
Dysuria * 2  2/101 (1.98%) 
Haematuria * 2  1/101 (0.99%) 
Oliguria * 2  1/101 (0.99%) 
Reproductive system and breast disorders   
Pelvic pain * 1  3/101 (2.97%) 
Vaginal haemorrhage * 2  3/101 (2.97%) 
Breast pain * 2  2/101 (1.98%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 2  19/101 (18.81%) 
Dyspnoea * 2  10/101 (9.90%) 
Oropharyngeal pain * 2  5/101 (4.95%) 
Productive cough * 2  5/101 (4.95%) 
Rhinorrhoea * 1  2/101 (1.98%) 
Dysphonia * 2  1/101 (0.99%) 
Dyspnoea exertional * 2  1/101 (0.99%) 
Nasal obstruction * 2  1/101 (0.99%) 
Pleural effusion * 2  1/101 (0.99%) 
Pulmonary embolism * 2  1/101 (0.99%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  46/101 (45.54%) 
Rash * 2  6/101 (5.94%) 
Pruritus * 2  5/101 (4.95%) 
Hyperhidrosis * 2  1/101 (0.99%) 
Pruritus generalised * 2  1/101 (0.99%) 
Rash erythematous * 2  1/101 (0.99%) 
Vascular disorders   
Lymphoedema * 2  2/101 (1.98%) 
Embolism * 2  1/101 (0.99%) 
Flushing * 2  1/101 (0.99%) 
Hypotension * 1  1/101 (0.99%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 18.0
2
Term from vocabulary, Select
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. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier: NCT01961544     History of Changes
Other Study ID Numbers: EKI-CT-1301
First Submitted: October 9, 2013
First Posted: October 11, 2013
Results First Submitted: August 16, 2016
Results First Posted: October 7, 2016
Last Update Posted: October 7, 2016