NCT00285675

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (planned)
• Sponsor: Novacea · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Androgen Independent Prostate Cancer (AIPC)
• Non Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	DN-101 (calcitriol) - Drug

Timeline

• Start date: 2006-04-01
• Completion: 2008-01-01
• First posted: 2006-02-02
• Last updated: 2006-05-31

Locations

13 sites across 2 countries: United States, Canada