Clinical trial NCT00055263: A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: advanced solid tumor malignancies
Lead sponsor: Novacea
Sponsor class: INDUSTRY
First posted: 2003-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Novacea
name: W. David Henner, MD, Ph.D.
role: STUDY_DIRECTOR
References: