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

July 24, 2009 updated by: Novacea

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novacea

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Registration Dates

First Submitted

February 21, 2003

First Submitted That Met QC Criteria

February 24, 2003

First Posted (Estimate)

February 25, 2003

Study Record Updates

Last Update Posted (Estimate)

July 28, 2009

Last Update Submitted That Met QC Criteria

July 24, 2009

Last Verified

February 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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