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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. Identifier: NCT00055263
Recruitment Status : Completed
First Posted : February 25, 2003
Last Update Posted : July 28, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Neoplasms Drug: DN-101 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Calcitriol

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00055263

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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
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Study Director: W. David Henner, MD, Ph.D. Novacea

Layout table for additonal information Identifier: NCT00055263    
Other Study ID Numbers: I-001
First Posted: February 25, 2003    Key Record Dates
Last Update Posted: July 28, 2009
Last Verified: February 2003
Keywords provided by Novacea:
advanced solid tumor malignancies
Additional relevant MeSH terms:
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Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents