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

Study:

A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)

Rationale:

n/a

Purpose:

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.

Study Status: Terminated

Recruiting:
n/a

Condition Intervention Phase
Prostate Cancer Drug: calcitriol
Drug: docetaxel
Phase 3

Verified by Novacea November, 2007

Sponsored by: Novacea
Information provided by: Novacea
ClinicalTrials.gov identifier: NCT00273338

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Howard I. Scher, MD., Study Chair
Kim N. Chi, M.D.., Study Chair
Ronald De-Wit, M.D.., Study Chair

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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