Overview

Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004

Status:
Unknown status

Trial end date:
2008-01-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novacea

Treatments:

Calcitriol
Docetaxel

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