- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01240421
An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory
May 21, 2015 updated by: Eisai Inc.
This expanded access program is an open-label, multi-center study, which will consist of a PreTreatment Phase and a Treatment Phase.
Patients with locally advanced or metastatic breast cancer who fulfill the eligibility criteria will be treated.
The program will continue in each country until eribulin is approved, reimbursed and launched in that country, or termination of the program by the Sponsor.
Study Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Description
Key Inclusion Criteria:
- Patient's oncologist must have documented experience in a prior eribulin clinical trial
- Recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy
Prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies:
- Anthracyclines, taxanes, and capecitabine
- Ixabepilone, in countries where this agent is marketed
- Trastuzumab, for Her-2 positive disease
- Hormonal therapy, in hormone receptor-positive disease
- All other commercially available therapies, e.g. gemcitabine or vinorelbine, used for the treatment of advanced breast cancer (see NCCN guidelines)
- ECOG performance status greater than or equal to 2
- Adequate kidney function: serum creatinine less than or equal to 2.0 mg/dL or creatinine clearance greater than or equal to 40 mL/min
- Adequate bone marrow function: absolute neutrophil count greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10 g/dL (can be corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L
- Adequate liver function: total bilirubin less than or equal to 1.5 x upper limit of normal (ULN), alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase less than or equal to 3 x ULN (or less than or equal to 5 x ULN in case of liver metastases). If alkaline phosphatase is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND patient also is known to have bone metastases, the liver specific alkaline phosphatase must be used to assess liver function instead of total alkaline phosphatase
- Willing and able to comply with all aspects of the treatment protocol
- Provision of written informed consent
- Female, aged at least 18 years
- Patients of childbearing potential must agree to be abstinent or to use a highly effective method of contraception
Key Exclusion Criteria:
Eligibility for any other eribulin study open in the same region
- Existing anti-cancer therapy-related toxicities of grade 2 or more, except that alopecia and grade 2 neuropathy are acceptable
- History of congestive heart failure with New York Heart Association Classification greater than grade II, unstable angina, myocardial infarction within the past 6 months or serious cardiac arrhythmia
- Electrocardiogram with QTc interval of greater than or equal to 500 msec based upon Bazett's formula (QTcB)
- The Investigator believes the patient to be medically unfit to receive eribulin or unsuitable for any other reason
- Pregnancy (positive B-hCG test) or breastfeeding
- Hypersensitivity to eribulin or any of the excipients
- Brain or subdural metastases, unless local therapy has been completed and use of corticosteroids for this indication has been discontinued for at least 4 weeks before starting treatment in this protocol. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting the treatment protocol
- History of or concomitant medical condition that, in the opinion of the Investigator, would compromise the patient's ability to safely complete the treatment protocol
- Known human immunodeficiency virus positivity, as neutropenia caused by eribulin treatment may make such patients particularly susceptible to infection.
- Meningeal carcinomatosis
- Pulmonary lymphangitic involvement resulting in pulmonary dysfunction requiring active treatment, including use of oxygen
- Receipt of any of the following treatments within the specified period before the start of treatment: 1) Any investigational drug within 4 weeks; 2) Chemotherapy, radiation, biological or targeted therapy within 2 weeks; 3) Hormonal therapy within 1 week.
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?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
March 1, 2011
Primary Completion (Anticipated)
March 1, 2015
Study Completion (Anticipated)
November 1, 2014
Study Registration Dates
First Submitted
October 1, 2010
First Submitted That Met QC Criteria
November 12, 2010
First Posted (Estimate)
November 15, 2010
Study Record Updates
Last Update Posted (Estimate)
May 22, 2015
Last Update Submitted That Met QC Criteria
May 21, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E7389-G000-398
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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