This trial is active, not recruiting.

Condition prostate cancer
Treatments calcitriol, docetaxel
Phase phase 2/phase 3
Sponsor Novacea
Collaborator Aventis Pharmaceuticals
Start date August 2002
End date December 2005
Trial size 250 participants
Trial identifier NCT00043576, ASCENT Trial, DN101-002


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Eligibility Criteria

Male participants at least 18 years old.

- 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

Additional Information

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)
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by Novacea.