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| Sponsor: | Novacea |
|---|---|
| Information provided by: | Novacea |
| ClinicalTrials.gov Identifier: | NCT00055263 |
Purpose
The purposes of this study are to:
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: DN-101 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
The following laboratory results:
Exclusion Criteria
Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97201 | |
| Study Director: | W. David Henner, MD, Ph.D. | Novacea |
More Information
| Study ID Numbers: | I-001 |
| Study First Received: | February 21, 2003 |
| Last Updated: | July 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00055263 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
advanced solid tumor malignancies |
|
Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Calcium Channel Agonists Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions |
Calcitriol Membrane Transport Modulators Neoplasms Therapeutic Uses Vitamins Vasoconstrictor Agents Micronutrients |