Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
Information source: Novacea
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Androgen Independent Prostate Cancer (AIPC); Non Small Cell Lung Cancer (NSCLC)
Intervention: DN-101 (calcitriol) - Drug (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Novacea
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.
Clinical Details
Official title: A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Tom Baker Cancer Centre, Calgary, Alberta T2N 4N2, Canada
Cross Cancer Institute, Department of Medicine, Edmonton, Alberta T6G 1Z2, Canada
Alta Bates Comprehensive Cancer Center, Berkeley, California 94704, United States
Kaiser Permanente Medical Group, Northern California, Vallejo, California 94589, United States
Pacific Hematology Oncology Associates, San Francisco, California 94115, 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
Oregon Health & Science University, Portland, Oregon 97239-3098, United States
Alta Bates Comprehensive Center, 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
Additional Information
Starting date: April 2006
Ending date: January 2008
Last updated: May 30, 2006
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