search
Back to results

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

Primary Purpose

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

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
DN-101 (calcitriol) - Drug
Sponsored by
Novacea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgen Independent Prostate Cancer (AIPC) focused on measuring Calcitriol, DN-101, Androgen Independent Prostate Cancer (AIPC), Prostate Cancer, Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alta Bates Comprehensive Cancer Center
  • Pacific Hematology Oncology Associates
  • Kaiser Permanente Medical Group, Northern California
  • Columbia Presbyterian Medical Center
  • Piedmont Hematology Oncology Associates
  • NW Kaiser Permanente Portland
  • Alta Bates Comprehensive Center
  • Oregon Health & Science University
  • University of Pittsburgh,William Copper Ambulatory Care, Pavillion Hellman Cancer Center
  • Tyler Cancer Center
  • Northwest Cancer Specialists Vancouver Office
  • Tom Baker Cancer Centre
  • Cross Cancer Institute, Department of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 31, 2006
Last Updated
May 30, 2006
Sponsor
Novacea
search

1. Study Identification

Unique Protocol Identification Number
NCT00285675
Brief Title
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

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novacea

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DN-101 (calcitriol) - Drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente Medical Group, Northern California
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Piedmont Hematology Oncology Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
NW Kaiser Permanente Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Alta Bates Comprehensive Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
University of Pittsburgh,William Copper Ambulatory Care, Pavillion Hellman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232-1305
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Northwest Cancer Specialists Vancouver Office
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute, Department of Medicine
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs