Trials / Terminated
TerminatedNCT00273338
DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])
A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,200 (estimated)
- Sponsor
- Novacea · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | calcitriol | |
| DRUG | docetaxel |
Timeline
- Start date
- 2006-01-01
- Completion
- 2007-11-01
- First posted
- 2006-01-09
- Last updated
- 2007-11-06
Locations
222 sites across 9 countries: United States, Canada, Czechia, Germany, Hungary, Puerto Rico, Romania, Serbia and Montenegro, Slovakia
Source: ClinicalTrials.gov record NCT00273338. Inclusion in this directory is not an endorsement.