NCT00055263

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Novacea · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	DN-101

Timeline

• Start date: 2002-03-01
• First posted: 2003-02-25
• Last updated: 2009-07-28

Locations

2 sites across 1 country: United States