- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00965523
Study of E7389 for Advanced or Metastatic Breast Cancer
July 14, 2013 updated by: Eisai Co., Ltd.
Phase II Extension Study of E7389 for Locally Advanced or Metastatic Breast Cancer
The purpose of this study (E7389-J081-224; hereafter referred to as Study 224) is to evaluate the safety of patients who continue to receive E7389 after completing the Phase II clinical study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed breast cancer by intravenously administering E7389.
Study Overview
Detailed Description
Study 224 (Extension Period) 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 (Core Period).
Thus, efficacy analyses performed in Study 221 were updated and reported with the additional data collected in Study 224.
Objective response rate (ORR) and the number of subjects with adverse events are reported as outcome measures because these were the outcome measures of Study 221 which is a main study in the combined data.
Also, safety analyses performed in Study 221 were updated and reported with the additional data collected in Study 224.
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan
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Kagoshima, Japan
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Aichi
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Nagoya, Aichi, Japan
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Hiroshima
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Kure, Hiroshima, Japan
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Tokyo
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Chuo, Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion criteria:
- Female patients with histologically or cytologically confirmed breast cancer.
- Patients who have received prior chemotherapy including anthracycline and taxane.
- Patients aged 20 - 74 years when giving informed consent and who have given written voluntary consent for participating in this study before the completion of Study 221.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
- Patients with a measurable lesion.
- Patients with an expected survival of ≥ 3 months from the start of study drug therapy.
- Female patients in whom continued administration of E7389 following Study 221 will be useful.
- Patients who have met the criteria for starting the next cycle in Study 221.
Namely, patients who meet all of the following criteria:
- Neutrophil count >= 1,500 /µL
- Platelet count >= 100,000 /µL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the upper limit of normal (ULN) in the facility or <= 5 times ULN in patients with hepatic metastasis)
- Total bilirubin <= 1.5 times ULN
- Serum creatinine <= 1.5 times ULN
- Non-hematological toxicity <= Grade 2 (excluding disease-associated events and laboratory abnormalities without clinical symptoms)
Exclusion criteria:
- Patients with systemic infection with a fever (≥38.0°C).
- Patients with pleural effusion, ascites or pericardial fluid requiring drainage.
- Patients with brain metastasis presenting clinical symptoms.
- Pregnant women, nursing mothers, or premenopausal women of childbearing potential. Premenopausal women of childbearing potential are defined as women who are <12 months after the latest menstruation and are positive in pregnancy test performed for enrollment or who have not taken the test and do not consent to take an appropriate contraceptive measure. Post-menopausal women must be amenorrheic for at least 12 months to make sure that they have no potential for becoming pregnant.
Patients with serious complications:
- Patients with uncontrollable cardiac disease such as ischemic heart disease and arrhythmia at a level of severity that needs to be treated (excluding left ventricular hypertrophy, mild left ventricular volume overload and mild right leg block that accompany hypertension)
- Patients with myocardial infarction within 6 months prior to study entry
- Patients with a complication of hepatic cirrhosis
- Patients with interstitial pneumonia and pulmonary fibrosis
- Patients with a bleeding tendency
- Patients with an active double cancer.
- Pregnant women or nursing mothers.
- Patients who have received extensive radiotherapy (≥30% of bone marrow).
- Patients who refuse to receive the supportive therapy of blood transfusion for myelosuppression.
- Patients who are participating in other clinical studies.
- Patients who are judged by the principal investigator or the other investigators to be inappropriate as patients in this clinical study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Eribulin Mesylate
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Eribulin mesylate 1.4 mg/m^2 intravenous infusion (IV) given over 2 to 5 minutes on Day 1 and 8 every 21 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of Subjects With Adverse Events.
Time Frame: Every week during treatment and up to 30 days after last dose of study treatment
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Every week during treatment and up to 30 days after last dose of study treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Every 6 weeks
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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.
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Every 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tatsuo Watanabe, Oncology Clinical Development Section. JAC PCU., Eisai, Co., Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
August 20, 2009
First Submitted That Met QC Criteria
August 24, 2009
First Posted (Estimate)
August 25, 2009
Study Record Updates
Last Update Posted (Estimate)
August 15, 2013
Last Update Submitted That Met QC Criteria
July 14, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E7389-J081-224
- E7389-J081-221
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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