Clinical trial NCT00285675: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Androgen Independent Prostate Cancer (AIPC)
Non Small Cell Lung Cancer (NSCLC)
Keywords: Calcitriol, DN-101, Androgen Independent Prostate Cancer (AIPC), Prostate Cancer, Non Small Cell Lung Cancer (NSCLC)
Lead sponsor: Novacea
Sponsor class: INDUSTRY
First posted: 2006-02-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

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