NeoplasmsPhase 1NCT00055263
A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies
A Phase 1 study testing DN-101 in people with Neoplasms, run by Novacea at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- DN-101
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2002to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Oregon Health & Science University
Portland, Oregon, 97201
About this study
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
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
Read the 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.
- Conditions
- Neoplasms
- Being tested
- DN-101
- Keywords
- advanced solid tumor malignancies
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DN-101Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2003 (estimated)
- Study startMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Novacea
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- W. David Henner, MD, Ph.D., Study director, Novacea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055263
- Sponsor's protocol ID
- I-001
- Status last verified
- Feb 2003
- First submitted
- 21 Feb 2003
- Last updated
- 28 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00055263
- Acronym / sponsor ID
- I-001
- Conditions
- Neoplasms
- Keywords
- advanced solid tumor malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- NovaceaIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- First posted
- 25 Feb 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DN-101 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. David Henner, MD, Ph.D. study director
Novacea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DN-101 in people with Neoplasms, run by Novacea at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2009.