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ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2005 by Novacea.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00043576
First Posted: August 13, 2002
Last Update Posted: March 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aventis Pharmaceuticals
Information provided by:
Novacea
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Drug: calcitriol Drug: docetaxel Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 2/3 Multicenter, Randomized, Double Blind Study of Docetaxel (Taxotere) Plus DN-101 or Placebo in Androgen Independent Prostate Cancer (AIPC)

Resource links provided by NLM:


Further study details as provided by Novacea:

Estimated Enrollment: 250
Study Start Date: August 2002
Estimated Study Completion Date: December 2005
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043576


  Show 62 Study Locations
Sponsors and Collaborators
Novacea
Aventis Pharmaceuticals
Investigators
Study Chair: Tomasz Beer, MD Oregon Health and Science University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00043576     History of Changes
Other Study ID Numbers: DN101-002
ASCENT Trial
First Submitted: August 9, 2002
First Posted: August 13, 2002
Last Update Posted: March 12, 2009
Last Verified: February 2005

Keywords provided by Novacea:
Prostate Cancer
Androgen Independent Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Androgens
Calcitriol
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents