This trial is active, not recruiting.

Conditions androgen independent prostate cancer (aipc), non small cell lung cancer (nsclc)
Treatment dn-101 (calcitriol) - drug
Phase phase 2
Sponsor Novacea
Start date April 2006
End date January 2008
Trial size 25 participants
Trial identifier NCT00285675, 011-016


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2006.
Information provided to ClinicalTrials.gov by Novacea.