Prostate CancerPhase 2/3NCT00127478
A Long Term Safety Study With Atrasentan
A Phase 2/3 study testing Atrasentan in people with Prostate Cancer and Adenocarcinoma, run by Abbott at 15 sites in 5 countries.
Trial summary
The primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Adenocarcinoma
- What is being tested?
- Atrasentan
- How many people
- 166 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Jul 2001to Jun 2007
- Phase
- Phase 2/3
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 18 years, inclusive;
- Subject is currently active in an atrasentan clinical study OR has histologically or cytologically documented diagnosis of prostate adenocarcinoma and is considered hormone refractory;
- Karnofsky Performance Score greater than or equal to 60;
- Adequate hematologic function and liver function tests;
- No New York Heart Association (NYHA) class greater than or equal to 2.
Who cannot join
None listed.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
United States7 sites
South Florida Medical Research
Aventura, Florida, 33180
Prostate Oncology Specialists
Marina del Rey, California, 32589
Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter
New York, New York, 10003
University of Pittsburgh Department of Urology
Pittsburgh, Pennsylvania, 15232
ViaHealth Rochester General Hospital Center for Urology
Rochester, New York, 14609
Oregon Urology Specialist, Division of Clinical Research
Springfield, Oregon, 97477
Western Clinical Research, Inc.
Torrance, California, 90505
Canada5 sites
Ken Janz MD
Burlington, Ontario, 3V2CAN
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
McMaster Institute of Urology
Hamilton, Ontario, L8N 4A6
McGill University Health Center Royal VIctoria Hosptial
Montreal, Quebec, H3A1A1
CroMedia Prime/Prime Trials Vancouver Hospital
Vancouver, British Columbia, V5Z 1M9
Netherlands1 site
University Hospital Rotterdam, Department of Urology
Rotterdam
United Kingdom1 site
Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.
Crewe, CW1 4QT
About this study
Official title: A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan
The primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer.
- Conditions
- Prostate Cancer, Adenocarcinoma
- Being tested
- Atrasentan
- Keywords
- Hormone Refractory Prostate Cancer, Adenocarcinoma of the Prostate
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtrasentanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Every 12 weeks
Serious adverse events
Oncology-related events (OREs)
Deaths
Study drug exposure
Change from baseline in Karnofsky performance status
Vital signs
Stratification by treatment group from prior study
Secondary outcomes (1)
Safety and laboratory parameters
Measured: Every 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startJul 2001
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gary Gordon, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127478
- Sponsor's protocol ID
- M01-304
- Status last verified
- Nov 2007
- First submitted
- 4 Aug 2005
- Last updated
- 29 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan
- ClinicalTrials.gov ID
- NCT00127478
- Acronym / sponsor ID
- M01-304
- Conditions
- Prostate Cancer, Adenocarcinoma
- Keywords
- Hormone Refractory Prostate Cancer, Adenocarcinoma of the Prostate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2001
- Study completion
- Jun 2007 (actual)
- First posted
- 8 Aug 2005 (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 primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate 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
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Greater than or equal to 18 years, inclusive;
- Subject is currently active in an atrasentan clinical study OR has histologically or cytologically documented diagnosis of prostate adenocarcinoma and is considered hormone refractory;
- Karnofsky Performance Score greater than or equal to 60;
- Adequate hematologic function and liver function tests;
- No New York Heart Association (NYHA) class greater than or equal to 2.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Atrasentan | Drug | – |
Primary outcome
Adverse events
Time frame: Every 12 weeks
Serious adverse events
Oncology-related events (OREs)
Deaths
Study drug exposure
Change from baseline in Karnofsky performance status
Vital signs
Stratification by treatment group from prior study
1 secondary outcome
Safety and laboratory parameters
Time frame: Every 12 weeks
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 29 Nov 2007.
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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.
Gary Gordon, MD study director
Abbott
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Atrasentan in people with Prostate Cancer and Adenocarcinoma, run by Abbott at 15 sites in 5 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 5 inclusion and 0 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 29 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada, France, Netherlands, United Kingdom. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Adverse events (time frame: Every 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 29 Nov 2007.