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
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.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
W. David Henner, MD, Ph.D.
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Oregon Health & Science University||Portland, Oregon 97201|