Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004

Status unconfirmed · Phase 2

Conditions studied: Androgen Independent Prostate Cancer (AIPC), Non Small Cell Lung Cancer (NSCLC)

In brief

The purpose of this study is to monitor the safety of continued DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 (ASCENT) or DN101-004 (NSCLC) Studies.

Key facts

Study ID

NCT00285675

Run by

Novacea

People needed

25

Starts

2006-04-01

Expected to finish

2008-01-01

Last updated by the study team

2006-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior participation in DN101-002 or DN101-004 studies, where the subject received at least one dose of DN-101
• Able and willing to give written informed consent

You may not qualify if…

• Disease progression or unacceptable toxicity while previously enrolled in DN101-002 or DN101-004 studies
• Prior investigational therapy other than DN-101 within 30 days of enrollment
• Known hypersensitivity to calcitriol
• Pregnancy (women of childbearing potential only)
• Greater than 90 days has elapsed from termination of DN101-002 or DN101-004 studies

Where it is running

• Alta Bates Comprehensive Cancer Center — Berkeley, California, United States
• Pacific Hematology Oncology Associates — San Francisco, California, United States
• Kaiser Permanente Medical Group, Northern California — Vallejo, California, United States
• Columbia Presbyterian Medical Center — New York, New York, United States
• Piedmont Hematology Oncology Associates — Winston-Salem, North Carolina, United States
• NW Kaiser Permanente Portland — Portland, Oregon, United States
• Alta Bates Comprehensive Center — Portland, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pittsburgh,William Copper Ambulatory Care, Pavillion Hellman Cancer Center — Pittsburgh, Pennsylvania, United States
• Tyler Cancer Center — Tyler, Texas, United States
• Northwest Cancer Specialists Vancouver Office — Vancouver, Washington, United States
• Tom Baker Cancer Centre — Calgary, Alberta, Canada
• Cross Cancer Institute, Department of Medicine — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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