Status:
UNKNOWN
Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
Lead Sponsor:
Novacea
Conditions:
Androgen Independent Prostate Cancer (AIPC)
Non Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
This is a multicenter, open-label trial of DN-101 and docetaxel combination therapy to monitor the safety of ongoing DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 or DN1...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00285675
Start Date
April 1 2006
End Date
January 1 2008
Last Update
May 31 2006
Active Locations (13)
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1
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
2
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
3
Kaiser Permanente Medical Group, Northern California
Vallejo, California, United States, 94589
4
Columbia Presbyterian Medical Center
New York, New York, United States, 10032