DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])
Stopped early · Phase 3
Conditions studied: Prostate Cancer
In brief
The primary objective of this study is: * To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer The secondary objectives of this study are: * To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots) * To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures) * A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.
Key facts
- Study ID
- NCT00273338
- Run by
- Novacea
- People needed
- 1200
- Starts
- 2006-01-01
- Expected to finish
- 2007-11-01
- Last updated by the study team
- 2007-11-06
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Histopathologically or cytologically proven adenocarcinoma of the prostate
- Documented metastatic prostate adenocarcinoma
- Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2
- Adequate hematologic, renal and hepatic function
- Life expectancy >= 3 months
You may not qualify if…
- Prior chemotherapy, except estramustine
- Prior chemotherapy with docetaxel
- Prior isotope therapy (e.g., strontium-89, samarium-153, etc.)
- One or more contraindications to the use of corticosteroids
- History of cancer-related hypercalcemia
Where it is running
- Northwest Alabama Cancer Center — Muscle Shoals, Alabama, United States
- Alaska Clinical Research Center — Anchorage, Alaska, United States
- Hematology Associates - AOA — Phoenix, Arizona, United States
- Premiere Oncology of Arizona — Scottsdale, Arizona, United States
- Northern Arizona Hematology & Oncology Associates, AOA — Sedona, Arizona, United States
- Southern Arizona VA Healthcare System — Tucson, Arizona, United States
- U of Arizona / Arizona Cancer Center — Tucson, Arizona, United States
- Genesis Cancer Center — Hot Springs, Arkansas, United States
- Tower Cancer Research Foundation — Beverly Hills, California, United States
- Pacific Shores Medical Group — Long Beach, California, United States
- The Angeles Clinic and Research Institute, Inc. — Los Angeles, California, United States
- UCLA department of Urology — Los Angeles, California, United States
- Veterans Affairs Northern California Health Care System — Martinez, California, United States
- Sutter Gould Medical Foundation — Modesto, California, United States
- Monterey Bay Oncology — Monterey, California, United States
- Comprehensive Cancer Center at — Palm Springs, California, United States
- Sutter Cancer Center — Sacramento, California, United States
- UCD Cancer Center-Clinical Trials — Sacramento, California, United States
- Sharp Memorial Hospital — San Diego, California, United States
- California Pacific Medical Center — San Francisco, California, United States
- Stanford University — Stanford, California, United States
- Rocky Mountain Cancer Centers — Colorado Springs, Colorado, United States
- Georgetown University Lombardi Cancer Center — Washington D.C., District of Columbia, United States
- Pasco Hernando Oncology Associates, P.A. — 14529 Cortez Blvd., Florida, United States
- Birmingham Hematology & Oncology Associates, LLC — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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