Trials / Approved For Marketing
Approved For MarketingNCT01240421
An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Eisai Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- —
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eribulin Mesylate | At a dose of 1.4 mg/m2 as a 2 to 5 minute intravenous bolus on Days 1 and 8 of a 21-day cycle. |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2015-03-01
- Completion
- 2014-11-01
- First posted
- 2010-11-15
- Last updated
- 2015-05-22
Locations
14 sites across 3 countries: Belgium, Canada, France
Source: ClinicalTrials.gov record NCT01240421. Inclusion in this directory is not an endorsement.