drugset / Trial / NCT00273338

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

NCT00273338

Phase 3 Terminated 1200 enrolled Novacea
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

EvaluationDrugModalityDoseRoute
Subject Calcitriol Small molecule
Subject Docetaxel Small molecule

Indications