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

Non Small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00285675
• Other study ID #: 011-016
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 31, 2006
• Last updated: May 30, 2006
• Start date: April 2006
• Est. completion date: January 2008

Study information

• Verified date: January 2006
• Source: Novacea
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Androgen Independent Prostate Cancer (AIPC)
• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer (NSCLC)
• Prostatic Neoplasms

Intervention

Drug:
• DN-101 (calcitriol) - Drug

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute, Department of Medicine	Edmonton	Alberta
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Columbia Presbyterian Medical Center	New York	New York
United States	University of Pittsburgh,William Copper Ambulatory Care, Pavillion Hellman Cancer Center	Pittsburgh	Pennsylvania
United States	Alta Bates Comprehensive Center	Portland	Oregon
United States	NW Kaiser Permanente Portland	Portland	Oregon
United States	Oregon Health & Science University	Portland	Oregon
United States	Pacific Hematology Oncology Associates	San Francisco	California
United States	Tyler Cancer Center	Tyler	Texas
United States	Kaiser Permanente Medical Group, Northern California	Vallejo	California
United States	Northwest Cancer Specialists Vancouver Office	Vancouver	Washington
United States	Piedmont Hematology Oncology Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novacea

Countries where clinical trial is conducted

United States,  Canada,