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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00055263

Enrollment

Registered

2003-02-25

Start date

2002-03-31

Completion date

Unknown

Last updated

2009-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

advanced solid tumor malignancies

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.

Interventions

DRUGDN-101

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026