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Study Of Eribulin (E7389) In Patients With Advanced Solid Tumors And Normal Or Reduced Hepatic Function As Per Child-Pugh System

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ClinicalTrials.gov Identifier: NCT00706095
Recruitment Status : Completed
First Posted : June 27, 2008
Results First Posted : January 30, 2012
Last Update Posted : March 27, 2012
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Intervention Drug: E7389
Enrollment 18
Recruitment Details This study was recruited at 2 centers in The Netherlands during the period of Feb 2008 to Jan 2010.
Pre-assignment Details  
Arm/Group Title E7389 1.4 mg/m^2 E7389 1.1 mg/m^2 E7389 0.7 mg/m^2
Hide Arm/Group Description E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function. E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A) E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
Period Title: Overall Study
Started 6 7 5
Completed 0 0 0
Not Completed 6 7 5
Reason Not Completed
Progressive Disease             4             5             3
Clinical Progression             1             2             2
Withdrawal by Subject             1             0             0
Arm/Group Title E7389 1.4 mg/m^2 E7389 1.1 mg/m^2 E7389 0.7 mg/m^2 Total
Hide Arm/Group Description E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function. E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A) E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B) Total of all reporting groups
Overall Number of Baseline Participants 6 7 5 18
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 7 participants 5 participants 18 participants
60.2  (5.98) 59.9  (4.88) 65.2  (2.68) 61.4  (5.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 5 participants 18 participants
Female
1
  16.7%
5
  71.4%
1
  20.0%
7
  38.9%
Male
5
  83.3%
2
  28.6%
4
  80.0%
11
  61.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 6 participants 7 participants 5 participants 18 participants
6 7 5 18
1.Primary Outcome
Title Mean (SD) Pharmacokinetic (PK) Parameter Area Under Concentration Time Curve From Zero to Infinity (AUC0-oo)
Hide Description [Not Specified]
Time Frame Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title E7389 1.4 mg/m^2 E7389 1.1 mg/m^2 E7389 0.7 mg/m^2
Hide Arm/Group Description:
E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
Overall Number of Participants Analyzed 6 7 5
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
600  (267.1) 731  (288.3) 720  (407.4)
2.Primary Outcome
Title Mean (SD) Pharmacokinetic (PK) Parameter Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title E7389 1.4 mg/m^2 E7389 1.1 mg/m^2 E7389 0.7 mg/m^2
Hide Arm/Group Description:
E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
Overall Number of Participants Analyzed 6 7 5
Mean (Standard Deviation)
Unit of Measure: ng/mL
186  (67.4) 147  (47.6) 113  (47.2)
3.Primary Outcome
Title Best Overall Response Per Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
Time Frame throughout the study and up to 30 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title E7389 1.4 mg/m^2 E7389 1.1 mg/m^2 E7389 0.7 mg/m^2
Hide Arm/Group Description:
E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
Overall Number of Participants Analyzed 6 7 5
Measure Type: Number
Unit of Measure: Number of Participants
Best Overall Response - Complete Response 0 0 0
Best Overall Response - Partial Response 0 0 0
Best Overall Response - Stable Disease 4 1 4
Best Overall Response - Progressive Disease 2 5 1
Best Overall Response - Missing 0 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title E7389 1.4 mg/m^2 E7389 1.1 mg/m^2 E7389 0.7 mg/m^2
Hide Arm/Group Description E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function. E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A) E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
All-Cause Mortality
E7389 1.4 mg/m^2 E7389 1.1 mg/m^2 E7389 0.7 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
E7389 1.4 mg/m^2 E7389 1.1 mg/m^2 E7389 0.7 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   4/7 (57.14%)   3/5 (60.00%) 
Gastrointestinal disorders       
Duodenal Obstruction  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Gastrointestinal Hemorrhage  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Ileus  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Esophageal Varices Hemorrhage  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Vomiting  1/6 (16.67%)  0/7 (0.00%)  0/5 (0.00%) 
Injury, poisoning and procedural complications       
Rib Fracture  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Investigations       
Blood Bilirubin Increased  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Blood Creatinine Increased  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1/6 (16.67%)  0/7 (0.00%)  1/5 (20.00%) 
Musculoskeletal and connective tissue disorders       
Back Pain  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Malignant Ascites  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Malignant Neoplasm Progression  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Psychiatric disorders       
Confusional State  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders       
Pleural Effusion  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E7389 1.4 mg/m^2 E7389 1.1 mg/m^2 E7389 0.7 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   7/7 (100.00%)   5/5 (100.00%) 
Blood and lymphatic system disorders       
Neutropenia  1/6 (16.67%)  2/7 (28.57%)  3/5 (60.00%) 
Anemia  1/6 (16.67%)  1/7 (14.29%)  1/5 (20.00%) 
Thrombocytopenia  0/6 (0.00%)  0/7 (0.00%)  2/5 (40.00%) 
Gastrointestinal disorders       
Nausea  3/6 (50.00%)  3/7 (42.86%)  2/5 (40.00%) 
Vomiting  1/6 (16.67%)  4/7 (57.14%)  2/5 (40.00%) 
Constipation  2/6 (33.33%)  2/7 (28.57%)  1/5 (20.00%) 
Diarrhea  1/6 (16.67%)  2/7 (28.57%)  2/5 (40.00%) 
Abdominal Pain  2/6 (33.33%)  0/7 (0.00%)  1/5 (20.00%) 
Abdominal Pain Upper  0/6 (0.00%)  1/7 (14.29%)  2/5 (40.00%) 
Stomatitis  1/6 (16.67%)  2/7 (28.57%)  0/5 (0.00%) 
Abdominal Distention  0/6 (0.00%)  2/7 (28.57%)  0/5 (0.00%) 
Dry Mouth  1/6 (16.67%)  1/7 (14.29%)  0/5 (0.00%) 
Hematochezia  0/6 (0.00%)  1/7 (14.29%)  1/5 (20.00%) 
Melena  0/6 (0.00%)  1/7 (14.29%)  1/5 (20.00%) 
General disorders       
Fatigue  2/6 (33.33%)  6/7 (85.71%)  3/5 (60.00%) 
Edema Peripheral  0/6 (0.00%)  1/7 (14.29%)  2/5 (40.00%) 
Pyrexia  0/6 (0.00%)  1/7 (14.29%)  1/5 (20.00%) 
Investigations       
Weight Decreased  1/6 (16.67%)  2/7 (28.57%)  2/5 (40.00%) 
Blood Bilirubin Increased  0/6 (0.00%)  2/7 (28.57%)  1/5 (20.00%) 
Aspartate Aminotransferase Increased  0/6 (0.00%)  1/7 (14.29%)  1/5 (20.00%) 
Blood Creatinine Increased  0/6 (0.00%)  2/7 (28.57%)  0/5 (0.00%) 
Metabolism and nutrition disorders       
Anorexia  0/6 (0.00%)  3/7 (42.86%)  1/5 (20.00%) 
Dehydration  1/6 (16.67%)  0/7 (0.00%)  2/5 (40.00%) 
Musculoskeletal and connective tissue disorders       
Muscle Spasms  1/6 (16.67%)  0/7 (0.00%)  3/5 (60.00%) 
Back Pain  1/6 (16.67%)  0/7 (0.00%)  1/5 (20.00%) 
Muscular Weakness  1/6 (16.67%)  1/7 (14.29%)  0/5 (0.00%) 
Muscular Stiffness  0/6 (0.00%)  1/7 (14.29%)  1/5 (20.00%) 
Myalgia  1/6 (16.67%)  1/7 (14.29%)  0/5 (0.00%) 
Nervous system disorders       
Peripheral Sensory Neuropathy  1/6 (16.67%)  0/7 (0.00%)  4/5 (80.00%) 
Dysgeusia  1/6 (16.67%)  1/7 (14.29%)  1/5 (20.00%) 
Headache  1/6 (16.67%)  1/7 (14.29%)  0/5 (0.00%) 
Paresthesia  2/6 (33.33%)  0/7 (0.00%)  0/5 (0.00%) 
Peripheral Motor Neuropathy  0/6 (0.00%)  0/7 (0.00%)  2/5 (40.00%) 
Psychiatric disorders       
Confusional State  0/6 (0.00%)  2/7 (28.57%)  1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1/6 (16.67%)  1/7 (14.29%)  0/5 (0.00%) 
Dysphonia  1/6 (16.67%)  1/7 (14.29%)  0/5 (0.00%) 
Dyspnea  0/6 (0.00%)  2/7 (28.57%)  0/5 (0.00%) 
Pharyngolaryngeal Pain  1/6 (16.67%)  1/7 (14.29%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia  1/6 (16.67%)  5/7 (71.43%)  4/5 (80.00%) 
Rash  4/6 (66.67%)  1/7 (14.29%)  0/5 (0.00%) 
Vascular disorders       
Hypotension  0/6 (0.00%)  1/7 (14.29%)  1/5 (20.00%) 
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: Eisai Inc.
Organization: Eisai Call Center
Phone: 888-422-4743
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00706095     History of Changes
Other Study ID Numbers: E7389-E044-108
First Submitted: February 4, 2008
First Posted: June 27, 2008
Results First Submitted: December 22, 2011
Results First Posted: January 30, 2012
Last Update Posted: March 27, 2012