An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Commercially Available Therapies

Eisai Limited0 sites500 target enrollmentMay 6, 2010

Overview

No summary available.

Registry

who.int

Start Date

May 6, 2010

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•Have recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti\-cancer therapy
•Had prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies:
•o Anthracyclines, taxanes, and capecitabine
•o Ixabepilone, in countries where this agent is marketed
•o Trastuzumab, for Her\-2 positive disease
•o Hormonal therapy, in hormone receptor\-positive disease
•o All other commercially available therapies, e.g. gemcitabine or vinorelbine, used for the treatment of advanced breast cancer (See NCCN guidelines)
•Have an ECOG performance status \= 2
•Have a serum creatinine \= 2\.0 mg/dL or creatinine clearance \= 40 mL/min according to Cockcroft and Gault formula
•Have an absolute neutrophil count \= 1\.5 x 109/L, hemoglobin \= 10 g/dL (can be corrected by growth factor or transfusion), and platelet count \= 100 x 109/L

•Are eligible for any other eribulin study that is open in the same region
•Have existing anti\-cancer therapy\-related toxicities of grade \= 2, except that alopecia and grade 2 neuropathy are acceptable
•Have a history of congestive heart failure with New York Heart Association Classification \> II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia
•Have an electrocardiogram with QTc interval \= 500 msec based upon Bazett’s formula (QTcB)
•The Investigator believes the subject to be medically unfit to receive eribulin or unsuitable for any other reason
•Are females who are pregnant (positive ß\-hCG test) or breastfeeding
•Are hypersensitive to eribulin or any of the excipients
•Have brain or subdural metastases, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this treatment protocol. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting the treatment protocol
•Have a history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject’s ability to safely complete the treatment protocol
•Are known to be human immunodeficiency virus positive because the neutropenia caused by the eribulin treatment may make such subjects particularly susceptible to infection.