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A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies
This study has been completed.
First Received: February 21, 2003   Last Updated: June 23, 2005   History of Changes
Sponsored by: Novacea
Information provided by: Novacea
ClinicalTrials.gov Identifier: NCT00055263
  Purpose

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

Condition Intervention Phase
Neoplasms
Drug: DN-101
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novacea:

Estimated Enrollment: 60
Study Start Date: March 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055263

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Novacea
Investigators
Study Director: W. David Henner, MD, Ph.D. Novacea
  More Information

Additional Information:
No publications provided

Study ID Numbers: I-001
Study First Received: February 21, 2003
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00055263     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Novacea:
advanced solid tumor malignancies

Study placed in the following topic categories:
Calcitriol

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009