Spots Global Cancer Trial Database for Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
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Trial Identification
Brief Title: Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
Official Title: A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
Study ID: NCT00285675
Interventions
Study Description
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 DN101-004 studies. For subjects enrolled in DN101-002 study, only subjects randomized to the DN-101 treatment arm and are currently receiving study drug (including subjects on study suspension / holiday) will be included in the current study. For subjects enrolled in DN101-004 study, only subjects who are receiving study treatment will be included. Safety will be assessed throughout the study. Safety evaluations will consist of a modified physical exam (vital signs and weight) and laboratory assessments. Modified physical exam should be performed at the beginning of each treatment cycle. Docetaxel-related laboratory assessments will be performed per standard of care as noted in the labeling. DN-101-related laboratory assessments for serum calcium and serum creatinine will be performed at the beginning of each treatment cycle. Clinically significant abnormal laboratory values will be reported as adverse events.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
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