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
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
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
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