Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2005 by Novacea.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
Novacea
ClinicalTrials.gov Identifier:
NCT00043576
First received: August 9, 2002
Last updated: March 10, 2009
Last verified: February 2005
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043576

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00043576     History of Changes
Other Study ID Numbers: DN101-002, ASCENT Trial
Study First Received: August 9, 2002
Last Updated: March 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Novacea:
Prostate Cancer
Androgen Independent Prostate Cancer

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

ClinicalTrials.gov processed this record on November 27, 2014