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Trial record 38 of 157 for:    eribulin

QT Interval Prolongation Study of Eribulin Mesylate (E7389) in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT01106248
Recruitment Status : Completed
First Posted : April 19, 2010
Results First Posted : April 13, 2012
Last Update Posted : April 13, 2012
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Solid Tumor
Intervention Drug: Eribulin Mesylate
Enrollment 26
Recruitment Details This study was recruited at 5 centers in France from Feb 2009 to Jul 2009.
Pre-assignment Details  
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description 1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
Period Title: Overall Study
Started 26
Completed 23
Not Completed 3
Reason Not Completed
Adverse Event             1
Administrative             2
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description 1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
55.9  (12.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
13
  50.0%
Male
13
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 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
1
   3.8%
White
22
  84.6%
More than one race
0
   0.0%
Unknown or Not Reported
3
  11.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 26 participants
26
1.Primary Outcome
Title Mean Time-matched, Baseline Corrected QTcF at Any Time Point Postdosing.
Hide Description The primary endpoint is mean time-matched, baseline corrected QTcF at any time point postdosing. This was to determine the effect of eribulin on cardiac repolarization as measured by QT/QTc interval.
Time Frame 48 hours postdose after Day 1 and after Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description:
1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: msec
Postdosing Day 1 2  (12.3)
Postdosing Day 8 11  (18.7)
2.Secondary Outcome
Title Pharmacokinetic Profile of Eribulin Mesylate: Observed Maximal Plasma Concentration (Cmax)
Hide Description Pharmacokinetic profile of eribulin mesylate (Cmax).
Time Frame Days 1 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description:
1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 516.5  (137.91)
Day 8 502.4  (138.31)
3.Secondary Outcome
Title To Assess Best Overall Response Using RECIST Criteria in Patients With Measurable Disease.
Hide Description [Not Specified]
Time Frame 21 day cycle
Outcome Measure Data Not Reported
4.Secondary Outcome
Title To Further Explore the Safety and Tolerability of Eribulin Mesylate When Administered on Days 1 and 8 of a 21-day Cycle in Patients With Solid Tumors.
Hide Description [Not Specified]
Time Frame 21 day cycle
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Pharmacokinetic Profile of Eribulin Mesylate: Time to Maximum Observed Plasma Concentration (Tmax).
Hide Description Pharmacokinetic profile of eribulin mesylate (tmax).
Time Frame Days 1 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description:
1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
Overall Number of Participants Analyzed 26
Median (Full Range)
Unit of Measure: hours
Day 1
0.08
(0.07 to 0.25)
Day 8
0.08
(0.05 to 0.25)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description 1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 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   11/26 (42.31%) 
Blood and lymphatic system disorders   
Anemia  1/26 (3.85%) 
Eye disorders   
Diplopia  1/26 (3.85%) 
Gastrointestinal disorders   
Vomting  2/26 (7.69%) 
Subileus  1/26 (3.85%) 
General disorders   
General Physical Health Deterioration  5/26 (19.23%) 
Pyrexia  3/26 (11.54%) 
Asthenia  2/26 (7.69%) 
Non-Cardiac Chest Pain  1/26 (3.85%) 
Hepatobiliary disorders   
Hepatitis  1/26 (3.85%) 
Infections and infestations   
Bacteremia  1/26 (3.85%) 
Mastoiditis  1/26 (3.85%) 
Investigations   
Weight Decreased  1/26 (3.85%) 
Metabolism and nutrition disorders   
Anorexia  1/26 (3.85%) 
Musculoskeletal and connective tissue disorders   
Bone Pain  3/26 (11.54%) 
Nervous system disorders   
Headache  1/26 (3.85%) 
Peripheral Motor Neuropathy  1/26 (3.85%) 
Peripheral Sensory Neuropathy  1/26 (3.85%) 
Psychiatric disorders   
Depression  1/26 (3.85%) 
Renal and urinary disorders   
Renal Failure  1/26 (3.85%) 
Urinary Retention  1/26 (3.85%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1/26 (3.85%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Eribulin Mesylate
Affected / at Risk (%)
Total   26/26 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia  16/26 (61.54%) 
Anemia  12/26 (46.15%) 
Leukopenia  10/26 (38.46%) 
Lymphopenia  6/26 (23.08%) 
Thrombocytopenia  1/26 (3.85%) 
Paratracheal Lymphadenopathy  1/26 (3.85%) 
Cardiac disorders   
Atrial Fibrillation  2/26 (7.69%) 
Tachycardia  1/26 (3.85%) 
Ear and labyrinth disorders   
Deafness  1/26 (3.85%) 
Tinnitis  1/26 (3.85%) 
Vertigo  1/26 (3.85%) 
Eye disorders   
Conjunctivitis  1/26 (3.85%) 
Diplopia  1/26 (3.85%) 
Gastrointestinal disorders   
Constipation  16/26 (61.54%) 
Nausea  12/26 (46.15%) 
Vomiting  11/26 (42.31%) 
Diarrhea  9/26 (34.62%) 
Abdominal Pain  3/26 (11.54%) 
Abdominal Pain Upper  2/26 (7.69%) 
Stomatitis  2/26 (7.69%) 
Bezoar  1/26 (3.85%) 
Dry Mouth  1/26 (3.85%) 
Dysphagia  1/26 (3.85%) 
Fecal Incontinence  1/26 (3.85%) 
Gastroesophageal Reflux Disease  1/26 (3.85%) 
Esophageal Pain  1/26 (3.85%) 
Subileus  1/26 (3.85%) 
Toothache  1/26 (3.85%) 
General disorders   
Asthenia  14/26 (53.85%) 
Pyrexia  9/26 (34.62%) 
Fatigue  5/26 (19.23%) 
General Physical Health Deterioration  5/26 (19.23%) 
Peripheral Edema  4/26 (15.38%) 
Mucosal Inflammation  2/26 (7.69%) 
Chills  1/26 (3.85%) 
Malaise  1/26 (3.85%) 
Non-Cardiac Chest Pain  1/26 (3.85%) 
Hepatobiliary disorders   
Hepatic Pain  2/26 (7.69%) 
Cholestasis  1/26 (3.85%) 
Hepatitis  1/26 (3.85%) 
Infections and infestations   
Oral Herpes  2/26 (7.69%) 
Urinary Tract Infection  2/26 (7.69%) 
Bacteremia  1/26 (3.85%) 
Bronchitis  1/26 (3.85%) 
Catheter Related Infection  1/26 (3.85%) 
Fungal Skin Infection  1/26 (3.85%) 
Mastoiditis  1/26 (3.85%) 
Sinusitis  1/26 (3.85%) 
Tracheitis  1/26 (3.85%) 
Investigations   
Alanine Aminotransferase Increased  3/26 (11.54%) 
Aspartate Aminotransferase Increased  3/26 (11.54%) 
Weight Decreased  3/26 (11.54%) 
Gamma Glutamyltransferase Increased  2/26 (7.69%) 
Alanine Aminotransferase Decreased  1/26 (3.85%) 
Blood Alkaline Phosphatase Increased  1/26 (3.85%) 
Blood Bilirubin Increased  1/26 (3.85%) 
Gamma Glutamyltransferase Decreased  1/26 (3.85%) 
Weight Increased  1/26 (3.85%) 
Musculoskeletal and connective tissue disorders   
Bone Pain  5/26 (19.23%) 
Myalgia  5/26 (19.23%) 
Back Pain  4/26 (15.38%) 
Arthralgia  2/26 (7.69%) 
Muscular Weakness  2/26 (7.69%) 
Musculoskeletal Chest Pain  2/26 (7.69%) 
Pain in Extremity  2/26 (7.69%) 
Muscle Spasms  1/26 (3.85%) 
Musculoskeletal Stiffness  1/26 (3.85%) 
Nervous system disorders   
Headache  6/26 (23.08%) 
Dysgeusia  3/26 (11.54%) 
Parasthesia  3/26 (11.54%) 
Peripheral Sensory Neuropathy  2/26 (7.69%) 
Presyncope  2/26 (7.69%) 
Dizziness  1/26 (3.85%) 
Intracranial Pressure Increased  1/26 (3.85%) 
Neuralgia  1/26 (3.85%) 
Paraparesis  1/26 (3.85%) 
Peripheral Motor Neuropathy  1/26 (3.85%) 
Tongue Paralysis  1/26 (3.85%) 
Psychiatric disorders   
Insomnia  4/26 (15.38%) 
Anxiety  2/26 (7.69%) 
Confusional State  2/26 (7.69%) 
Agitation  1/26 (3.85%) 
Depression  1/26 (3.85%) 
Renal and urinary disorders   
Urinary Retention  2/26 (7.69%) 
Hematuria  1/26 (3.85%) 
Renal Failure  1/26 (3.85%) 
Urinary Incontinence  1/26 (3.85%) 
Respiratory, thoracic and mediastinal disorders   
Cough  4/26 (15.38%) 
Dyspnea  4/26 (15.38%) 
Dysphonia  2/26 (7.69%) 
Rhinorrhea  2/26 (7.69%) 
Epistaxis  1/26 (3.85%) 
Oropharyngeal Pain  1/26 (3.85%) 
Skin and subcutaneous tissue disorders   
Alopecia  11/26 (42.31%) 
Dermatitis  1/26 (3.85%) 
Dermatitis Contact  1/26 (3.85%) 
Erythema  1/26 (3.85%) 
Pruritis  1/26 (3.85%) 
Rash  1/26 (3.85%) 
Vascular disorders   
Hypotension  1/26 (3.85%) 
Lymphoedema  1/26 (3.85%) 
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: Dr. Peter Tarassoff
Organization: Eisai
Phone: 888-422-4743
Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT01106248     History of Changes
Other Study ID Numbers: E7389-E044-110
First Submitted: April 14, 2010
First Posted: April 19, 2010
Results First Submitted: December 22, 2011
Results First Posted: April 13, 2012
Last Update Posted: April 13, 2012