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A Study to Determine the Metabolism and Elimination of Carbon-14 Labeled Eribulin Acetate (14C-Eribulin) in Patients With Advanced Solid Tumors

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: NCT00908908
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : January 27, 2012
Last Update Posted : March 9, 2012
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 Advanced Solid Tumors
Intervention Drug: eribulin
Enrollment 6
Recruitment Details This study was recruited at 1 center in The Netherlands during the period of Mar 2009 to Jun 2009.
Pre-assignment Details  
Arm/Group Title Eribulin
Hide Arm/Group Description Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
Period Title: Overall Study
Started 6
Adverse Event 0
Withdrawl by Subject 0
Administrative/Other 0
Physician Decision 0
Completed 6
Not Completed 0
Arm/Group Title Eribulin
Hide Arm/Group Description Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
57.5  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 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
6
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces.
Hide Description [Not Specified]
Time Frame 312 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title 14C-eribulin/Eribulin
Hide Arm/Group Description:
Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: percent recovery
90.4  (11.73)
2.Primary Outcome
Title Pharmacokinetics: AUC (0-t) for Total Radioactivity in Plasma
Hide Description Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring total radioactivity exposure.
Time Frame Between Days 1 and 8 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title 14C-eribulin/Eribulin
Hide Arm/Group Description:
Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: ng eq*hr/mL/mg
269  (153.4)
3.Primary Outcome
Title Pharmacokinetics AUC (0-t) for Eribulin in Plasma
Hide Description Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring exposure to eribulin.
Time Frame Between Days 1 and 8 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title 14C-eribulin/Eribulin
Hide Arm/Group Description:
Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: ng eq*hr/mL/mg
301  (164.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eribulin
Hide Arm/Group Description Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
All-Cause Mortality
Eribulin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Eribulin
Affected / at Risk (%)
Total   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eribulin
Affected / at Risk (%)
Total   4/6 (66.67%) 
Blood and lymphatic system disorders   
Anemia  1/6 (16.67%) 
Cardiac disorders   
Palpitations  1/6 (16.67%) 
Gastrointestinal disorders   
Abdominal Pain Upper  1/6 (16.67%) 
Eructation  1/6 (16.67%) 
Nausea  1/6 (16.67%) 
General disorders   
Fatigue  4/6 (66.67%) 
Pyrexia  1/6 (16.67%) 
Infections and infestations   
Pneumonia  1/6 (16.67%) 
Injury, poisoning and procedural complications   
Accidental Overdose  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders   
Back Pain  1/6 (16.67%) 
Flank Pain  1/6 (16.67%) 
Myalgia  1/6 (16.67%) 
Nervous system disorders   
Headache  2/6 (33.33%) 
Dysgeusia  1/6 (16.67%) 
Paresthesia  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  2/6 (33.33%) 
Skin and subcutaneous tissue disorders   
Alopecia  1/6 (16.67%) 
Night Sweats  1/6 (16.67%) 
Scab  1/6 (16.67%) 
Skin Exfoliation  1/6 (16.67%) 
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
Layout table for Results Point of Contact information
Name/Title: Eisai Inc.
Organization: Eisai Call Center
Phone: 888-422-4743
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00908908    
Other Study ID Numbers: E7389-E044-103
First Submitted: May 20, 2009
First Posted: May 27, 2009
Results First Submitted: December 22, 2011
Results First Posted: January 27, 2012
Last Update Posted: March 9, 2012