A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies

Condition(s) targeted: Neoplasms

Intervention: DN-101 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novacea

Official(s) and/or principal investigator(s):
W. David Henner, MD, Ph.D., Study Director, Affiliation: Novacea

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

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Roswell Park Cancer Institute, Buffalo, New York 14263, United States

Oregon Health & Science University, Portland, Oregon 97201, United States

Sponsor website

Starting date: March 2002
Last updated: June 23, 2005