ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere
- Conditions
- Prostate Cancer
- Registration Number
- NCT00043576
- Lead Sponsor
- Novacea
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (62)
Tower Hematology Oncology Medical Group
🇺🇸Los Angeles, California, United States
Texas Oncology, P.A.
🇺🇸Dallas, Texas, United States
Kaiser- Northern California
🇺🇸Vallejo, California, United States
Georgia Cancer Specialists
🇺🇸Tucker, Georgia, United States
Loyola University Medical
🇺🇸Maywood, Illinois, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Washington Cancer Care
🇺🇸Seattle, Washington, United States
Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
Pacific Hematology Oncology Associates
🇺🇸San Francisco, California, United States
University of Miami-Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Oregon Health & Sciences University
🇺🇸Portland, Oregon, United States
NW Kaiser Permanente Portland
🇺🇸Portland, Oregon, United States
Toronto-Sunnybrook Regional Cancer Center
🇨🇦Toronto, Ontario, Canada
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Texas Cancer Care
🇺🇸Fort Worth, Texas, United States
North Texas Regional Cancer Center
🇺🇸Plano, Texas, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Vancouver Cancer Center
🇨🇦Vancouver, British Columbia, Canada
Princess Margaret Hospital, University Health Network
🇨🇦Toronto, Ontario, Canada
Prostate Oncology Specialist/Pacific Clinical Research
🇺🇸Marina Del Rey, California, United States
Arizona Cancer Center/Southern Arizona VA HCS
🇺🇸Tucson, Arizona, United States
Montgomery Cancer Center
🇺🇸Montgomery, Alabama, United States
Arizona Cancer Center- Scottsdale
🇺🇸Scottsdale, Arizona, United States
Arizona Cancer Center- Tucson
🇺🇸Tucson, Arizona, United States
California Cancer Care
🇺🇸Greenbrae, California, United States
University of Arkansas for Medical Sciences / Central AR VA
🇺🇸Little Rock, Arkansas, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Oncology Hematology Associates, Paudre Calley Cancer Ctr.
🇺🇸Fort Collins, Colorado, United States
San Diego Cancer Center
🇺🇸Vista, California, United States
Oncology Hematology Consultants
🇺🇸Sarasota, Florida, United States
Urologic Associates- P.C.
🇺🇸Davenport, Iowa, United States
Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Georgia Urology, P.A.
🇺🇸Atlanta, Georgia, United States
Midwest Cancer Research Group
🇺🇸Skokie, Illinois, United States
Associates in Oncology Hematology P.C.
🇺🇸Rockville, Maryland, United States
Metro Minnesota CCOP
🇺🇸St. Louis Park, Minnesota, United States
Oncology Hematology Care
🇺🇸Crestview HIlls, Kentucky, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
New Mexico Cancer Care Associates
🇺🇸Santa Fe, New Mexico, United States
Mid Ohio Oncology Hematology, Inc.
🇺🇸Columbus, Ohio, United States
Lincoln Medical & Mental Health Center
🇺🇸Bronx, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Union State Bank Cancer Center
🇺🇸Nyack, New York, United States
Columbia Presbyterian Medical Center
🇺🇸New York, New York, United States
Raleigh Hematology Oncology Clinic
🇺🇸Cary, North Carolina, United States
The Cleveland Clinic Foundation, Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Charleston Hematology Oncology
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina - Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Professional Quality Research
🇺🇸Austin, Texas, United States
University Oncology/ Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
Boston Baskin Cancer Group
🇺🇸Memphis, Tennessee, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Urology Associates of North Texas
🇺🇸Ft. Worth, Texas, United States
CHUM / Notre-Dame Hospital
🇨🇦Montreal, Quebec, Canada
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Centre hospitalier universitaire de Quebec, Hotel-Dieu de Quebec
🇨🇦Quebec, Canada
UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
Univ. of Nebraska Medical Center/VA Hospital
🇺🇸Omaha, Nebraska, United States
Sharp Healthcare
🇺🇸San Diego, California, United States