DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])

• Status: Terminated
• Trial end date: 2007-11-01

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.

• Phase: Phase 3

Details

• Lead Sponsor: Novacea
• Treatments: Androgens; Calcitriol; Docetaxel