ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere - Tabular View

Tracking Information

First Received Date ^ICMJE

August 9, 2002

Last Updated Date

March 10, 2009

Start Date ^ICMJE

August 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00043576 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere

Official Title ^ICMJE

A Phase 2/3 Multicenter, Randomized, Double Blind Study of Docetaxel (Taxotere) Plus DN-101 or Placebo in Androgen Independent Prostate Cancer (AIPC)

Brief Summary

The purposes of this study are to determine if DN-101 plus Taxotere lowers PSA levels, delays or limits disease progression and is safe with minimal side effects.

Detailed Description

DN-101 is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA). It is a newly formulated pill that contains high amounts of calcitriol, a naturally occurring hormone and the biologically active form of vitamin D. Administration of DN-101 results in much higher blood levels of calcitriol than the body can produce from dietary vitamin D or vitamin D supplements. These higher levels of calcitriol are associated with anti-cancer effects in laboratory models of human cancer. Laboratory models also indicate that calcitriol has synergy with many commonly used chemotherapeutic agents used to treat cancer.

Calcitriol, at very low doses, is currently approved for use in patients with chronic kidney failure. DN-101 was specifically designed for cancer and contains 30 times the amount of calcitriol found in the calcitriol pill commercially available today. In order to take an amount of calcitriol equivalent to 1 DN-101 pill, cancer patients would need to swallow 30 pills of the approved, low dose formulation. DN-101 represents a breakthrough in the use of calcitriol in the clinic, because it contains high concentrations of calcitriol and makes it more feasible for patients to stay on regimen.

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: calcitriol
Drug: docetaxel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

250

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Three rising PSA measurements OR a new metastatic lesion
Adequate liver and kidney function
Ongoing hormonal therapy
No hospitalization for angina, heart attack or congestive heart failure within the last 12 months
No kidney stones in the last 5 years

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00043576

Responsible Party

Study ID Numbers ^ICMJE

DN101-002, ASCENT Trial

Study Sponsor ^ICMJE

Novacea

Collaborators ^ICMJE

Aventis Pharmaceuticals

Investigators ^ICMJE

Study Chair:

Tomasz Beer, MD

Oregon Health and Science University

Information Provided By

Novacea

Verification Date

February 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP