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

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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

Key facts

Study ID

NCT00055263

Run by

Novacea

People needed

60

Starts

2002-03-01

Last updated by the study team

2009-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States
• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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