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Trial record 100 of 157 for:    eribulin

A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer

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ClinicalTrials.gov Identifier: NCT01432886
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : March 30, 2015
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: E7389
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title E7389 With Weekly Trastuzumab E7389 With Tri-weekly Trastuzumab
Hide Arm/Group Description Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses. Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
Period Title: Overall Study
Started 6 6
Completed 6 [1] 6 [1]
Not Completed 0 0
[1]
Discontinuation met per discontinuation criteria
Arm/Group Title E7389 With Weekly Trastuzumab E7389 With Tri-weekly Trastuzumab Total
Hide Arm/Group Description Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses. Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses. Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
64.7  (5.05) 49.2  (10.32) 56.9  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
6
 100.0%
6
 100.0%
12
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Japanese Number Analyzed 6 participants 6 participants 12 participants
6 6 12
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicity (DLT)
Hide Description For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.
Time Frame Up to 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The DLT analysis set included those participants who received at least one dose of study drug and had a DLT assessment in cycle 1 (3 weeks) without deviations from the eribulin mesylate/trastuzumab dosing regimens and other major protocol prescripts. Participants with a DLT, regardless of this criterion, were also included in the DLT analysis set.
Arm/Group Title E7389 With Weekly Trastuzumab E7389 With Tri-weekly Trastuzumab
Hide Arm/Group Description:
Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: Participants
0 0
2.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description The number of subjects who developed 'treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.
Time Frame From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation.
Arm/Group Title E7389 With Weekly Trastuzumab E7389 With Triweekly Trastuzumab
Hide Arm/Group Description:
Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.

Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle.

Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.

Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: Participants
6 6
Time Frame From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
Adverse Event Reporting Description The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
 
Arm/Group Title E7389 With Weekly Trastuzumab E7389 With Tri-weekly Trastuzumab
Hide Arm/Group Description Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses. Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
All-Cause Mortality
E7389 With Weekly Trastuzumab E7389 With Tri-weekly Trastuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
E7389 With Weekly Trastuzumab E7389 With Tri-weekly Trastuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
E7389 With Weekly Trastuzumab E7389 With Tri-weekly Trastuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  4/6 (66.67%)  4/6 (66.67%) 
Febrile neutropenia * 1  0/6 (0.00%)  1/6 (16.67%) 
Leukopenia * 1  6/6 (100.00%)  6/6 (100.00%) 
Lymphopenia * 1  0/6 (0.00%)  3/6 (50.00%) 
Neutropenia * 1  6/6 (100.00%)  6/6 (100.00%) 
Cardiac disorders     
Atrioventricular block second degree * 1  1/6 (16.67%)  0/6 (0.00%) 
Palpitations * 1  2/6 (33.33%)  0/6 (0.00%) 
Eye disorders     
Ocular hyperaemia * 1  0/6 (0.00%)  1/6 (16.67%) 
Vision blurred * 1  1/6 (16.67%)  0/6 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper * 1  1/6 (16.67%)  0/6 (0.00%) 
Cheilitis * 1  1/6 (16.67%)  0/6 (0.00%) 
Constipation * 1  2/6 (33.33%)  0/6 (0.00%) 
Dental caries * 1  1/6 (16.67%)  0/6 (0.00%) 
Diarrhoea * 1  0/6 (0.00%)  1/6 (16.67%) 
Gastrooesophageal reflux disease * 1  0/6 (0.00%)  1/6 (16.67%) 
Nausea * 1  1/6 (16.67%)  2/6 (33.33%) 
Oral dysaesthesia * 1  1/6 (16.67%)  0/6 (0.00%) 
Stomatitis * 1  1/6 (16.67%)  1/6 (16.67%) 
Toothache * 1  1/6 (16.67%)  0/6 (0.00%) 
Vomiting * 1  0/6 (0.00%)  3/6 (50.00%) 
General disorders     
Chest discomfort * 1  1/6 (16.67%)  1/6 (16.67%) 
Implant site pain * 1  1/6 (16.67%)  0/6 (0.00%) 
Inflammation * 1  1/6 (16.67%)  0/6 (0.00%) 
Influenza like illness * 1  0/6 (0.00%)  1/6 (16.67%) 
Infusion site extravasation * 1  1/6 (16.67%)  0/6 (0.00%) 
Injection site reaction * 1  2/6 (33.33%)  0/6 (0.00%) 
Malaise * 1  3/6 (50.00%)  0/6 (0.00%) 
Mucosal inflammation * 1  1/6 (16.67%)  0/6 (0.00%) 
Oedema peripheral * 1  1/6 (16.67%)  0/6 (0.00%) 
Pyrexia * 1  2/6 (33.33%)  3/6 (50.00%) 
Infections and infestations     
Gastroenteritis viral * 1  0/6 (0.00%)  1/6 (16.67%) 
Influenza * 1  0/6 (0.00%)  1/6 (16.67%) 
Lung infection * 1  0/6 (0.00%)  2/6 (33.33%) 
Nasopharyngitis * 1  0/6 (0.00%)  1/6 (16.67%) 
Tonsillitis * 1  1/6 (16.67%)  1/6 (16.67%) 
Injury, poisoning and procedural complications     
Contrast media reaction * 1  0/6 (0.00%)  1/6 (16.67%) 
Excoriation * 1  1/6 (16.67%)  0/6 (0.00%) 
Infusion related reaction * 1  0/6 (0.00%)  1/6 (16.67%) 
Investigations     
Aspartate aminotransferase increased * 1  2/6 (33.33%)  1/6 (16.67%) 
Blood alkaline phosphatase increased * 1  0/6 (0.00%)  1/6 (16.67%) 
Blood creatine phosphokinase increased * 1  3/6 (50.00%)  0/6 (0.00%) 
Ejection fraction decreased * 1  1/6 (16.67%)  1/6 (16.67%) 
Gamma-glutamyltransferase increased * 1  0/6 (0.00%)  1/6 (16.67%) 
Alanine aminotransferase increased * 1  2/6 (33.33%)  1/6 (16.67%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  4/6 (66.67%)  1/6 (16.67%) 
Hyperlipidaemia * 1  1/6 (16.67%)  0/6 (0.00%) 
Hypertriglyceridaemia * 1  1/6 (16.67%)  2/6 (33.33%) 
Hypophosphataemia * 1  0/6 (0.00%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/6 (16.67%)  0/6 (0.00%) 
Groin pain * 1  1/6 (16.67%)  0/6 (0.00%) 
Muscle spasms * 1  2/6 (33.33%)  0/6 (0.00%) 
Myalgia * 1  4/6 (66.67%)  0/6 (0.00%) 
Osteoarthritis * 1  0/6 (0.00%)  1/6 (16.67%) 
Pain in extremity * 1  1/6 (16.67%)  0/6 (0.00%) 
Spondylolisthesis * 1  0/6 (0.00%)  1/6 (16.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour pain * 1  0/6 (0.00%)  1/6 (16.67%) 
Nervous system disorders     
Dysgeusia * 1  2/6 (33.33%)  2/6 (33.33%) 
Headache * 1  0/6 (0.00%)  2/6 (33.33%) 
Neuropathy peripheral * 1  1/6 (16.67%)  0/6 (0.00%) 
Peripheral sensory neuropathy * 1  3/6 (50.00%)  0/6 (0.00%) 
Tremor * 1  1/6 (16.67%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1  1/6 (16.67%)  0/6 (0.00%) 
Organising pneumonia * 1  1/6 (16.67%)  0/6 (0.00%) 
Oropharyngeal pain * 1  0/6 (0.00%)  1/6 (16.67%) 
Pneumothorax * 1  1/6 (16.67%)  0/6 (0.00%) 
Wheezing * 1  0/6 (0.00%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders     
Acne * 1  1/6 (16.67%)  0/6 (0.00%) 
Alopecia * 1  5/6 (83.33%)  3/6 (50.00%) 
Dermatitis acneiform * 1  1/6 (16.67%)  0/6 (0.00%) 
Dermatitis contact * 1  0/6 (0.00%)  1/6 (16.67%) 
Nail discolouration * 1  1/6 (16.67%)  0/6 (0.00%) 
Nail disorder * 1  1/6 (16.67%)  0/6 (0.00%) 
Rash * 1  4/6 (66.67%)  1/6 (16.67%) 
Urticaria * 1  0/6 (0.00%)  1/6 (16.67%) 
Vascular disorders     
Phlebitis * 1  1/6 (16.67%)  0/6 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Tadashi Nakanishi
Organization: Eisai Co., Ltd.
Phone: 81-3-3817-5252 ext 5252
Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01432886     History of Changes
Other Study ID Numbers: E7389-J081-107
First Submitted: September 12, 2011
First Posted: September 13, 2011
Results First Submitted: March 19, 2015
Results First Posted: March 30, 2015
Last Update Posted: October 7, 2016