drugset / Trial / NCT01084655
Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is an open-label, multicenter, Phase 1/2 study of TAK-700 in combination with docetaxel and prednisone that will evaluate the safety and pharmacokinetics (PK) of the combination and will allow estimation of prostate-specific antigen (PSA) response in men with metastatic castration-resistant prostate cancer (mCRPC).
Timeline
- Start
- 2010-07
- Primary completion
- 2013-01
- Completion
- 2016-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Orteronel | Small molecule | 200 mg | Oral |
| Subject | Orteronel | Small molecule | 400 mg | Oral |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |