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
18 Years
N/A
Both
Neoplasms
Trial Information
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
W. David Henner, MD, Ph.D.
Investigator Role:
Study Director
Investigator Affiliation:
Novacea
Authority:
United States: Food and Drug Administration
Study ID:
I-001
NCT ID:
NCT00055263
Start Date:
March 2002
Completion Date:
Related Keywords:
- Neoplasms
- advanced solid tumor malignancies
- Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Oregon Health & Science University | Portland, Oregon 97201 |
