Trials / Completed
CompletedNCT00322374
Phase I Combination w/ Epirubicin
A Phase I Study of Ixabepilone in Combination With Epirubicin in Patients With Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- R-Pharm · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment. Tumor response assessment in evaluable participants was done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ixabepilone | Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study. |
| DRUG | Epirubicin | Infusion, intravenous (IV): 75 mg/m\^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m². |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2009-02-01
- Completion
- 2009-02-01
- First posted
- 2006-05-05
- Last updated
- 2016-03-10
- Results posted
- 2010-08-10
Locations
2 sites across 2 countries: France, Italy
Source: ClinicalTrials.gov record NCT00322374. Inclusion in this directory is not an endorsement.