drugset / Trial / NCT00510718
A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
Phase 1
Completed
140 enrolled
Pfizer
Astellas Pharma Inc · collabMedivation LLC, a wholly owned subsidiary of Pfizer Inc. · collab
Open-labelTreatment
Summary
This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
Timeline
- Start
- 2007-07-23
- Primary completion
- 2008-12-08
- Completion
- 2018-04-02
Publications
- Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.
- Scher HI, Beer TM, Higano CS, Anand A, Taplin ME, Efstathiou E, Rathkopf D, Shelkey J, Yu EY, Alumkal J, Hung D, Hirmand M, Seely L, Morris MJ, Danila DC, Humm J, Larson S, Fleisher M, Sawyers CL; Prostate Cancer Foundation/Department of Defense Prostate Cancer Clinical Trials Consortium. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. Lancet. 2010 Apr 24;375(9724):1437-46. doi: 10.1016/S0140-6736(10)60172-9. Epub 2010 Apr 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enzalutamide | Other / unclassified | 30 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 60 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 150 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 240 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 360 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 480 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 600 mg | Oral |