drugset / Trial / NCT01953536
Safety and Efficacy Study of Vintafolide and Vintafolide Plus Paclitaxel Compared to Paclitaxel Alone in Participants With Triple Negative Breast Cancer (TNBC) (MK-8109-004)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy and safety of vintafolide alone compared to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive folate receptor (FR) triple negative breast cancer (TNBC). The primary hypothesis of this study is the vintafolide alone and/or vintafolide + paclitaxel will improve progression free survival (PFS) in participants with FR (100%) TNBC compared to paclitaxel alone.
Timeline
- Start
- 2014-04
- Primary completion
- 2016-11
- Completion
- 2016-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EC20 | Diagnostic / imaging agent | 0.1 mg | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Vintafolide | Other / unclassified | 2.5 mg | Intravenous |
| Background | Cimetidine | Small molecule | 300 mg | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Promethazine | Small molecule | 25 mg | Intravenous |
| Background | Promethazine | Small molecule | 50 mg | Intravenous |
| Background | Ranitidine | Unknown | 50 mg | Intravenous |
| Background | folic acid | Other / unclassified | 0.5 mg | Intravenous |