Trials / Completed
CompletedNCT00568022
A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer
A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- R-Pharm · Industry
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese participants with metastatic breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ixabepilone | Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m\^2, once every 3 weeks, up to 6 cycles |
| DRUG | Capecitabine | Capecitabine: Tablets, Oral, 1650(2000)mg/m\^2, twice daily for 2 weeks, one week off, up to 6 cycles |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2010-01-01
- Completion
- 2010-01-01
- First posted
- 2007-12-05
- Last updated
- 2016-03-10
- Results posted
- 2011-08-17
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00568022. Inclusion in this directory is not an endorsement.