drugset / Trial / NCT00273338
DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is: * To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer The secondary objectives of this study are: * To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots) * To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures) * A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.
Timeline
- Start
- 2006-01
- Primary completion
- —
- Completion
- 2007-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcitriol | Small molecule | — | — |
| Subject | Docetaxel | Small molecule | — | — |