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

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ClinicalTrials.gov Identifier: NCT00285675
Recruitment Status : Unknown
Verified January 2006 by Novacea.
Recruitment status was:  Active, not recruiting
First Posted : February 2, 2006
Last Update Posted : May 31, 2006
Sponsor:
Information provided by:
Novacea

Tracking Information
First Submitted Date  ICMJE January 31, 2006
First Posted Date  ICMJE February 2, 2006
Last Update Posted Date May 31, 2006
Study Start Date  ICMJE April 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00285675 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
Official Title  ICMJE A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Androgen Independent Prostate Cancer (AIPC)
  • Non Small Cell Lung Cancer (NSCLC)
Intervention  ICMJE Drug: DN-101 (calcitriol) - Drug
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: January¬†31,¬†2006)
25
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00285675
Other Study ID Numbers  ICMJE 011-016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Novacea
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novacea
Verification Date January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP