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

NCT ID: NCT00055263

Last Updated: 2009-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

DN-101

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novacea

INDUSTRY

Sponsor Role: lead

Principal Investigators

W. David Henner, MD, Ph.D.

Role: STUDY_DIRECTOR

Novacea

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

I-001

Identifier Type: -

Identifier Source: org_study_id