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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 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on 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 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like 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. 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 Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Participants frequently obtain the most expert healthcare available for their 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 condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: Neoplasms
Status: Recruiting
Sponsor(s): Novacea ,
Synopsis: 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
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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 exclusion criteria are not to be enrolled in this study: - Significant active medical illness (other than current cancer) which in the opinion of the investigator would preclude protocol treatment - History of cancer-related hypercalcemia, known hypercalcemia, or vitamin D toxicity - Uncontrolled heart failure - Kidney stones (calcium salt) within the past 5 years - Prior investigational therapy within the past 30 days - Prior use of calcitriol within the past 3 months or known hypersensitivity to calcitriol - Concurrent active treatment for cancer with the exception of treatment for androgen-independent prostate cancer - Excluded concomitant medications: calcium- or magnesium-containing antacids, bile-resin binders, bisphosphonates, or calcium supplements; ketoconazole or related compounds
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
W.Henner, Study Director, Novacea
Roswell Park Cancer Institute *Recruiting*
Buffalo, New York, 14263
United States
Recruiting Diane Noel 716-845-1439
Oregon Health & Science University *Recruiting*
Portland, Oregon, 97201
United States
Recruiting Kristi Eilers 503-494-2897
Additional Information:
Study ID Numbers: DN101-001;
Study Start Date: March 2002
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055263
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4. 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
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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
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