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

This study has been completed.
Sponsor:
Information provided by:
Novacea
ClinicalTrials.gov Identifier:
NCT00055263
First received: February 21, 2003
Last updated: July 24, 2009
Last verified: February 2003
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00055263     History of Changes
Other Study ID Numbers: I-001
Study First Received: February 21, 2003
Last Updated: July 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Novacea:
advanced solid tumor malignancies

Additional relevant MeSH terms:
Neoplasms
Calcitriol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014