Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
1 other identifier
interventional
25
2 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2006
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2006
CompletedFirst Posted
Study publicly available on registry
February 2, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedMay 31, 2006
January 1, 2006
January 31, 2006
May 30, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novacealead
Study Sites (13)
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704, United States
Pacific Hematology Oncology Associates
San Francisco, California, 94115, United States
Kaiser Permanente Medical Group, Northern California
Vallejo, California, 94589, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, 27103, United States
NW Kaiser Permanente Portland
Portland, Oregon, 97227, United States
Alta Bates Comprehensive Center
Portland, Oregon, 97239-3098, United States
Oregon Health & Science University
Portland, Oregon, 97239-3098, United States
University of Pittsburgh,William Copper Ambulatory Care, Pavillion Hellman Cancer Center
Pittsburgh, Pennsylvania, 15232-1305, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Northwest Cancer Specialists Vancouver Office
Vancouver, Washington, 98684, United States
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute, Department of Medicine
Edmonton, Alberta, T6G 1Z2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 31, 2006
First Posted
February 2, 2006
Study Start
April 1, 2006
Study Completion
January 1, 2008
Last Updated
May 31, 2006
Record last verified: 2006-01