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Compassionate Use of Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Marketed Therapies

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ClinicalTrials.gov Identifier: NCT01142661
Recruitment Status : Completed
First Posted : June 11, 2010
Results First Posted : September 20, 2013
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: Eribulin Mesylate
Enrollment 9
Recruitment Details This study was recruited at 5 centers in the US during the period of Aug 2010 to Aug 2011.
Pre-assignment Details  
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
Period Title: Overall Study
Started 9
Completed 5
Not Completed 4
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             1
Physician Decision             1
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
55.2  (11.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
9
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
9
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Safety
Hide Description General safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.
Time Frame For duration of treatment, an average of 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description:
Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
9
2.Primary Outcome
Title Safety
Hide Description General safety will be assessed by monitoring and recording the number of patients with serious adverse events for duration of treatment which continued until disease progression, unacceptable toxicity or death.
Time Frame For duration of treatment, an average of 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description:
Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
All-Cause Mortality
Eribulin Mesylate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eribulin Mesylate
Affected / at Risk (%)
Total   7/9 (77.78%) 
Blood and lymphatic system disorders   
Febrile Neutropenia  1/9 (11.11%) 
Neutropenia  1/9 (11.11%) 
Cardiac disorders   
Tachycardia  1/9 (11.11%) 
Gastrointestinal disorders   
Hematemesis  1/9 (11.11%) 
Small Bowel Obstruction  1/9 (11.11%) 
Infections and infestations   
Pneumonia  1/9 (11.11%) 
Metabolism and nutrition disorders   
Hypokalemia  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders   
Alcohol Poisoning  1/9 (11.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Progressive Disease  4/9 (44.44%) 
Nervous system disorders   
Syncope  1/9 (11.11%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eribulin Mesylate
Affected / at Risk (%)
Total   9/9 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia  3/9 (33.33%) 
Anemia  1/9 (11.11%) 
Leukopenia  1/9 (11.11%) 
Splenomegaly  1/9 (11.11%) 
Congenital, familial and genetic disorders   
Thrombocytopenia  1/9 (11.11%) 
Eye disorders   
Tachyarrhythmia  1/9 (11.11%) 
Lacrimation Increased  1/9 (11.11%) 
Photopsia  1/9 (11.11%) 
Vision Impairment  1/9 (11.11%) 
Gastrointestinal disorders   
Vision Blurred  1/9 (11.11%) 
Constipation  4/9 (44.44%) 
Nausea  4/9 (44.44%) 
Abdominal Distension  2/9 (22.22%) 
Ascites  1/9 (11.11%) 
Gingival Bleeding  1/9 (11.11%) 
Diarrhea  1/9 (11.11%) 
Hypoaesthesia Oral  1/9 (11.11%) 
Oral Discomfort  1/9 (11.11%) 
Stomatitis  1/9 (11.11%) 
Vomiting  1/9 (11.11%) 
General disorders   
Abdominal Hernia  1/9 (11.11%) 
Fatigue  6/9 (66.67%) 
Peripheral Edema  2/9 (22.22%) 
Cyst  1/9 (11.11%) 
Mucosal Inflammation  1/9 (11.11%) 
Hepatobiliary disorders   
Jaundice  1/9 (11.11%) 
Infections and infestations   
Oral Herpes  1/9 (11.11%) 
Urinary Tract Infection  1/9 (11.11%) 
Injury, poisoning and procedural complications   
Skin Infection  1/9 (11.11%) 
Contusion  1/9 (11.11%) 
Investigations   
Mouth Ulceration  1/9 (11.11%) 
Neutrophil Count Decreased  2/9 (22.22%) 
Blood Alkaline Phosphatase Increased  1/9 (11.11%) 
Blood Bilirubin Increased  1/9 (11.11%) 
Hemoglobin Decreased  1/9 (11.11%) 
Occult Blood Positive  1/9 (11.11%) 
Metabolism and nutrition disorders   
Fluid Retention  1/9 (11.11%) 
Hypocalcemia  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  2/9 (22.22%) 
Back Pain  1/9 (11.11%) 
Muscle Spasms  1/9 (11.11%) 
Muscular Weakness  1/9 (11.11%) 
Musculoskeletal Chest Pain  1/9 (11.11%) 
Myalgia  1/9 (11.11%) 
Pain in Extremity  1/9 (11.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Decreased Appetite  1/9 (11.11%) 
Nervous system disorders   
Headache  2/9 (22.22%) 
Ataxia  1/9 (11.11%) 
Dysaesthesia  1/9 (11.11%) 
Neuropathy Peripheral  1/9 (11.11%) 
Peripheral Sensory Neuropathy  1/9 (11.11%) 
Pregnancy, puerperium and perinatal conditions   
Bone Pain  1/9 (11.11%) 
Psychiatric disorders   
Insomnia  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  2/9 (22.22%) 
Cough  1/9 (11.11%) 
Dyspnea  1/9 (11.11%) 
Oropharyngeal Pain  1/9 (11.11%) 
Upper Airway Cough Syndrome  1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Alopecia  1/9 (11.11%) 
Pruritis  1/9 (11.11%) 
Vascular disorders   
Phlebitis  1/9 (11.11%) 
Phlebitis Superficial  1/9 (11.11%) 
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: Prash Gopalakrishna
Organization: Eisai Inc.
Phone: 888-422-4743
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01142661     History of Changes
Other Study ID Numbers: E7389-G000-399
First Submitted: June 10, 2010
First Posted: June 11, 2010
Results First Submitted: April 29, 2013
Results First Posted: September 20, 2013
Last Update Posted: September 20, 2013