A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies
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
1 other identifier
interventional
60
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 21, 2003
CompletedFirst Posted
Study publicly available on registry
February 25, 2003
CompletedJuly 28, 2009
February 1, 2003
February 21, 2003
July 24, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novacealead
Study Sites (2)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Oregon Health & Science University
Portland, Oregon, 97201, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
W. David Henner, MD, Ph.D.
Novacea
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 21, 2003
First Posted
February 25, 2003
Study Start
March 1, 2002
Last Updated
July 28, 2009
Record last verified: 2003-02