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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055263
• Other study ID #: I-001
• Status: Completed
• Phase: Phase 1
• First received: February 21, 2003
• Last updated: July 24, 2009
• Start date: March 2002

Study information

• Verified date: February 2003
• Source: Novacea
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• DN-101

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Novacea

Country where clinical trial is conducted

United States,