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Trial record 69 of 157 for:    eribulin

Study of E7389 for Advanced or Metastatic 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: NCT00965523
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : August 15, 2013
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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 81
Recruitment Details Study 221 was conducted at 22 centers in Japan during the period of Jan 2008 to Sept 2009, and Study 224 was conducted at 5 centers in Japan from Aug 2009 to Jan 2011.
Pre-assignment Details Study 224 was designed to evaluate the safety and efficacy of E7389 by collecting data from subjects who continued receiving E7389 after being transferred from Study 221. Thus, combined data of Study 221 and Study 224 are reported.
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
Period Title: Study 221
Started 81 [1]
Completed 74
Not Completed 7
Reason Not Completed
Progressive Disease             4
Physician Decision             3
[1]
Study 221 (Safety Analysis Set).
Period Title: Study 224
Started 6 [1]
Completed 0
Not Completed 6
Reason Not Completed
Progressive Disease             5
Physician Decision             1
[1]
Six subjects continued into Study 224 from Study 221.
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
Demographic data were reported for 80 subjects, the Full Analysis Set, which is the primary efficacy analysis set in this study.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
53.6  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
80
 100.0%
Male
0
   0.0%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 80 participants
80
[1]
Measure Description: Full Analysis Set
1.Primary Outcome
Title Number of Subjects With Adverse Events.
Hide Description [Not Specified]
Time Frame Every week during treatment and up to 30 days after last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
Overall Number of Participants Analyzed 81
Measure Type: Number
Unit of Measure: Participants
81
2.Secondary Outcome
Title Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter [LD] of target lesions compared baseline sum of LD). Tumor assessments every 6 weeks.
Time Frame Every 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description:
Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: percentage of subjects
Objective Response Rate 21.3
Partial Response 21.3
Stable Disease 37.5
Progressive Disease 40.0
Not Evaluable 1.3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
All-Cause Mortality
Eribulin Mesylate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eribulin Mesylate
Affected / at Risk (%)
Total   14/81 (17.28%) 
Blood and lymphatic system disorders   
Neutropenia  1/81 (1.23%) 
Eye disorders   
Cataract  1/81 (1.23%) 
Gastrointestinal disorders   
Ascites  1/81 (1.23%) 
Gastritis Hemorrhagic  1/81 (1.23%) 
Nausea  1/81 (1.23%) 
Stomatitis  2/81 (2.47%) 
General disorders   
Malaise  1/81 (1.23%) 
Oedema  1/81 (1.23%) 
Pain  1/81 (1.23%) 
Pyrexia  1/81 (1.23%) 
Infections and infestations   
Infection  2/81 (2.47%) 
Injury, poisoning and procedural complications   
Upper Limb Fracture  1/81 (1.23%) 
Metabolism and nutrition disorders   
Dehydration  1/81 (1.23%) 
Hypercalcemia  1/81 (1.23%) 
Decreased Appetite  2/81 (2.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cancer Pain  1/81 (1.23%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1/81 (1.23%) 
Interstitial Lung Disease  1/81 (1.23%) 
Vascular disorders   
Hemorrhage  1/81 (1.23%) 
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   81/81 (100.00%) 
Blood and lymphatic system disorders   
Febrile Neutropenia  12/81 (14.81%) 
Leukopenia  80/81 (98.77%) 
Lymphopenia  44/81 (54.32%) 
Neutropenia  80/81 (98.77%) 
Thrombocytopenia  7/81 (8.64%) 
Anemia  7/81 (8.64%) 
Gastrointestinal disorders   
Constipation  14/81 (17.28%) 
Diarrhea  15/81 (18.52%) 
Nausea  36/81 (44.44%) 
Stomatitis  33/81 (40.74%) 
Vomiting  16/81 (19.75%) 
Abdominal Pain Upper  8/81 (9.88%) 
General disorders   
Fatigue  37/81 (45.68%) 
Malaise  11/81 (13.58%) 
Pain  9/81 (11.11%) 
Pyrexia  25/81 (30.86%) 
Chest Pain  5/81 (6.17%) 
Oedema  7/81 (8.64%) 
Oedema Peripheral  5/81 (6.17%) 
Infections and infestations   
Nasopharyngitis  22/81 (27.16%) 
Infection  6/81 (7.41%) 
Investigations   
Alanine Aminotransferase Increased  27/81 (33.33%) 
Aspartate Aminotransferase Increased  30/81 (37.04%) 
Blood Albumin Decreased  10/81 (12.35%) 
Blood Creatine Phophokinase Increased  23/81 (28.40%) 
Blood Glucose Increased  12/81 (14.81%) 
Blood Lactate Dehydrogenase Increased  16/81 (19.75%) 
C-Reactive Protein Increased  14/81 (17.28%) 
Gamma Glutamyltransferase Increased  22/81 (27.16%) 
Blood Urine Present  8/81 (9.88%) 
Hemoglobin Decreased  28/81 (34.57%) 
Weight Decreased  9/81 (11.11%) 
Blood Alkaline Phosphatase Increased  18/81 (22.22%) 
Red Blood Cell Count Decreased  5/81 (6.17%) 
Metabolism and nutrition disorders   
Decreased Appetite  38/81 (46.91%) 
Hyperglycemia  8/81 (9.88%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  14/81 (17.28%) 
Back Pain  5/81 (6.17%) 
Musculoskeletal Pain  6/81 (7.41%) 
Myalgia  8/81 (9.88%) 
Nervous system disorders   
Dizziness  9/81 (11.11%) 
Dysgeusia  27/81 (33.33%) 
Headache  13/81 (16.05%) 
Peripheral Sensory Neuropathy  19/81 (23.46%) 
Hypoaesthesia  5/81 (6.17%) 
Respiratory, thoracic and mediastinal disorders   
Cough  13/81 (16.05%) 
Oropharyngeal Pain  8/81 (9.88%) 
Skin and subcutaneous tissue disorders   
Alopecia  47/81 (58.02%) 
Rash  11/81 (13.58%) 
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: Tatsuo Watanabe, Study Director
Organization: Eisai
Phone: +81-3-3817-5252
Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00965523     History of Changes
Obsolete Identifiers: NCT00633100
Other Study ID Numbers: E7389-J081-224
E7389-J081-221
First Submitted: August 20, 2009
First Posted: August 25, 2009
Results First Submitted: December 22, 2011
Results First Posted: August 15, 2013
Last Update Posted: August 15, 2013