drugset / Trial / NCT01597193
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
Phase 1
Completed
101 enrolled
Pfizer
Astellas Pharma Inc · collabMedivation LLC, a wholly owned subsidiary of Pfizer Inc. · collab
Non-randomizedOpen-labelTreatment
Summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.
Timeline
- Start
- 2012-04-30
- Primary completion
- 2015-12-15
- Completion
- 2018-01-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Background | Anastrozole | Other / unclassified | 1 mg | Oral |
| Background | Exemestane | Small molecule | 25 mg | — |
| Background | Exemestane | Small molecule | 50 mg | — |
| Background | Fulvestrant | Small molecule | 500 mg | Intramuscular |