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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novacea
• Treatments: Calcitriol

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