Trials / Completed
CompletedNCT01432886
A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
A Phase 1 Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- Female
- Age
- 20 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E7389 | Eribulin mesylate (iv) will be administered on Day 1 and Day 8 of each cycle (3 weeks as 1 cycle). Trastuzumab (iv) will be administered as weekly use or tri-weekly use. Trastuzumab will be administered immediately after eribulin mesylate administration when used concomitantly. |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2013-08-01
- Completion
- 2013-12-01
- First posted
- 2011-09-13
- Last updated
- 2016-10-07
- Results posted
- 2015-03-30
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01432886. Inclusion in this directory is not an endorsement.