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

May 30, 2006 updated by: Novacea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute, Department of Medicine
  • United States
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • San Francisco, California, United States, 94115
        • Pacific Hematology Oncology Associates
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Group, Northern California
    • New York
      • New York, New York, United States, 10032
        • Columbia Presbyterian Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Hematology Oncology Associates
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health & Science University
      • Portland, Oregon, United States, 97227
        • NW Kaiser Permanente Portland
      • Portland, Oregon, United States, 97239-3098
        • Alta Bates Comprehensive Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232-1305
        • University of Pittsburgh,William Copper Ambulatory Care, Pavillion Hellman Cancer Center
    • Texas
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Washington
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists Vancouver Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novacea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion

January 1, 2008

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 2, 2006

Study Record Updates

Last Update Posted (Estimate)

May 31, 2006

Last Update Submitted That Met QC Criteria

May 30, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 011-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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