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A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00055263
Recruitment Status : Completed
First Posted : February 25, 2003
Last Update Posted : July 28, 2009
Sponsor:
Information provided by:
Novacea

Tracking Information
First Submitted Date  ICMJE February 21, 2003
First Posted Date  ICMJE February 25, 2003
Last Update Posted Date July 28, 2009
Study Start Date  ICMJE March 2002
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 NCT00055263 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 A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies
Official Title  ICMJE A Phase I, Open Label, Dose Escalation Study of a New Formulation of Calcitriol (DN-101) for Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Malignancies
Brief Summary

The purposes of this study are to:

  • Test the safety of DN-101 in patients with advanced malignancies
  • Understand how fast the body absorbs, processes, and eliminates DN-101
  • Determine the highest dose of DN-101 that is well tolerated by cancer patients
  • Learn how fast the body absorbs, processes, and eliminates DN-101 compared to the approved product
Detailed Description

Calcitriol, at low doses, is approved by the FDA for use in patients with chronic renal failure. However, much higher doses of calcitriol are needed for any possible anti-cancer effect. DN-101 is a new capsule that contains 30 times the amount of calcitriol found in the currently available calcitriol capsule. In order to take an amount of calcitriol equivalent to 1 capsule of DN-101, cancer patients would need to swallow 30 pills of the approved, low dose formulation.

DN-101 is a pill containing calcitriol, a chemical related to vitamin D that is immediately active in your body. The natural vitamin D found in dairy products or in typical vitamin pills, must be chemically changed by your liver and kidney into calcitriol before it is active. High doses of calcitriol had anti-cancer effects when tested in animals. DN-101 may have anticancer effects in your kind of cancer.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE Drug: DN-101
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 Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

  • Patients with advanced solid tumor malignancies
  • Patients with prostate cancer are eligible 1) if they have had a prostatectomy or radiation therapy and have a rising PSA, 2) if they have androgen sensitive prostate cancer and are on hormone therapy, or 3) if they have androgen independent prostate cancer and have failed hormone therapy
  • Patients with other types of malignancies will be required to have failed at least one potentially effective therapy prior to study entry
  • Life expectancy > 3 months
  • Age > 18 years
  • The following laboratory results:

    • Adequate hematologic function
    • Adequate renal function
    • Adequate liver function
    • Negative urine pregnancy test (females of childbearing potential only)
  • Willingness to use effective contraception by both males and females throughout the treatment period and for at least 2 months following treatment
  • Signed informed consent form

Exclusion Criteria

Patients who meet any of the following exclusion criteria are not to be enrolled in this study:

  • Significant active medical illness (other than current cancer) which in the opinion of the investigator would preclude protocol treatment
  • History of cancer-related hypercalcemia, known hypercalcemia, or vitamin D toxicity
  • Uncontrolled heart failure
  • Kidney stones (calcium salt) within the past 5 years
  • Prior investigational therapy within the past 30 days
  • Prior use of calcitriol within the past 3 months or known hypersensitivity to calcitriol
  • Concurrent active treatment for cancer with the exception of treatment for androgen-independent prostate cancer
  • Excluded concomitant medications: calcium- or magnesium-containing antacids, bile-resin binders, bisphosphonates, or calcium supplements; ketoconazole or related compounds
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00055263
Other Study ID Numbers  ICMJE I-001
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
Study Director: W. David Henner, MD, Ph.D. Novacea
PRS Account Novacea
Verification Date February 2003

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