Androgen Independent Prostate Cancer (AIPC)Phase 2NCT00285675
Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
A Phase 2 study testing DN-101 (calcitriol) - Drug in people with Androgen Independent Prostate Cancer (AIPC) and Non Small Cell Lung Cancer (NSCLC), run by Novacea at 13 sites in 2 countries.
Trial summary
The purpose of this study is to monitor the safety of continued DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 (ASCENT) or DN101-004 (NSCLC) Studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Androgen Independent Prostate Cancer (AIPC), Non Small Cell Lung Cancer (NSCLC)
- What is being tested?
- DN-101 (calcitriol) - Drug
- How many people
- 25 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Apr 2006to Jan 2008
- Phase
- Phase 2
- 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
- Prior participation in DN101-002 or DN101-004 studies, where the subject received at least one dose of DN-101
- Able and willing to give written informed consent
Who cannot join
- Disease progression or unacceptable toxicity while previously enrolled in DN101-002 or DN101-004 studies
- Prior investigational therapy other than DN-101 within 30 days of enrollment
- Known hypersensitivity to calcitriol
- Pregnancy (women of childbearing potential only)
- Greater than 90 days has elapsed from termination of DN101-002 or DN101-004 studies
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
Columbia Presbyterian Medical Center
New York, New York, 10032
University of Pittsburgh,William Copper Ambulatory Care, Pavillion Hellman Cancer Center
Pittsburgh, Pennsylvania, 15232-1305
NW Kaiser Permanente Portland
Portland, Oregon, 97227
Alta Bates Comprehensive Center
Portland, Oregon, 97239-3098
Oregon Health & Science University
Portland, Oregon, 97239-3098
Pacific Hematology Oncology Associates
San Francisco, California, 94115
Tyler Cancer Center
Tyler, Texas, 75702
Kaiser Permanente Medical Group, Northern California
Vallejo, California, 94589
Northwest Cancer Specialists Vancouver Office
Vancouver, Washington, 98684
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, 27103
Canada2 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute, Department of Medicine
Edmonton, Alberta, T6G 1Z2
About this study
Official title: A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
The purpose of this study is to monitor the safety of continued DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 (ASCENT) or DN101-004 (NSCLC) Studies.
Read the detailed description
This is a multicenter, open-label trial of DN-101 and docetaxel combination therapy to monitor the safety of ongoing DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 or DN101-004 studies. For subjects enrolled in DN101-002 study, only subjects randomized to the DN-101 treatment arm and are currently receiving study drug (including subjects on study suspension / holiday) will be included in the current study. For subjects enrolled in DN101-004 study, only subjects who are receiving study treatment will be included.
Safety will be assessed throughout the study. Safety evaluations will consist of a modified physical exam (vital signs and weight) and laboratory assessments. Modified physical exam should be performed at the beginning of each treatment cycle. Docetaxel-related laboratory assessments will be performed per standard of care as noted in the labeling. DN-101-related laboratory assessments for serum calcium and serum creatinine will be performed at the beginning of each treatment cycle. Clinically significant abnormal laboratory values will be reported as adverse events.
- Being tested
- DN-101 (calcitriol) - Drug
- Keywords
- Calcitriol, DN-101, Androgen Independent Prostate Cancer (AIPC), Prostate Cancer, Non Small Cell Lung Cancer (NSCLC)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DN-101 (calcitriol) - DrugDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startApr 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgen Independent Prostate Cancer (AIPC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Novacea
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285675
- Sponsor's protocol ID
- 011-016
- Status last verified
- Jan 2006
- First submitted
- 31 Jan 2006
- Last updated
- 31 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
- ClinicalTrials.gov ID
- NCT00285675
- Acronym / sponsor ID
- 011-016
- Keywords
- Calcitriol, DN-101, Androgen Independent Prostate Cancer (AIPC), Prostate Cancer, Non Small Cell Lung Cancer (NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants
- Lead sponsor
- NovaceaIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Jan 2008
- First posted
- 2 Feb 2006 (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 purpose of this study is to monitor the safety of continued DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 (ASCENT) or DN101-004 (NSCLC) Studies.
Detailed description
This is a multicenter, open-label trial of DN-101 and docetaxel combination therapy to monitor the safety of ongoing DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 or DN101-004 studies. For subjects enrolled in DN101-002 study, only subjects randomized to the DN-101 treatment arm and are currently receiving study drug (including subjects on study suspension / holiday) will be included in the current study. For subjects enrolled in DN101-004 study, only subjects who are receiving study treatment will be included.
Safety will be assessed throughout the study. Safety evaluations will consist of a modified physical exam (vital signs and weight) and laboratory assessments. Modified physical exam should be performed at the beginning of each treatment cycle. Docetaxel-related laboratory assessments will be performed per standard of care as noted in the labeling. DN-101-related laboratory assessments for serum calcium and serum creatinine will be performed at the beginning of each treatment cycle. Clinically significant abnormal laboratory values will be reported as adverse events.
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 (2 listed)
- Prior participation in DN101-002 or DN101-004 studies, where the subject received at least one dose of DN-101
- Able and willing to give written informed consent
Key exclusion criteria (5 listed)
- Disease progression or unacceptable toxicity while previously enrolled in DN101-002 or DN101-004 studies
- Prior investigational therapy other than DN-101 within 30 days of enrollment
- Known hypersensitivity to calcitriol
- Pregnancy (women of childbearing potential only)
- Greater than 90 days has elapsed from termination of DN101-002 or DN101-004 studies
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 (calcitriol) - Drug | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2006.
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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DN-101 (calcitriol) - Drug in people with Androgen Independent Prostate Cancer (AIPC) and Non Small Cell Lung Cancer (NSCLC), run by Novacea at 13 sites in 2 countries.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 31 May 2006.