Prostate CancerPhase 3NCT00046943
Atrasentan in Treating Patients With Prostate Cancer
A Phase 3 study testing atrasentan hydrochloride in people with Prostate Cancer, run by Abbott at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase III trial to determine the effectiveness of atrasentan in treating patients who have prostate cancer that has not responded to hormone therapy. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- atrasentan hydrochloride
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Jun 2007
- Phase
- Phase 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of hormone-refractory prostate cancer
- Completed protocol ABBOTT-M00-211 or ABBOTT-M00-244 within the past 30 days
- Disease progression OR
- Active in trial when double-blind treatment period ended
PATIENT CHARACTERISTICS:
Age
- 19 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm3
- Absolute neutrophil count greater than 1,000/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 9 g/dL
Hepatic
- Bilirubin less than 1.5 mg/dL
- AST and ALT no greater than 1.5 times upper limit of normal
Renal
- Creatinine clearance at least 40 mL/min
Cardiovascular
- No New York Heart Association class II-IV heart disease
Pulmonary
- No significant pulmonary disease requiring chronic or pulse steroid therapy within the past 3 months
Other
- Fertile patients must use 2 effective methods of contraception (1 must be barrier contraception) during and for 8 weeks after study
- No reason that would preclude study
- No significant comorbid condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 4 weeks since other prior cytotoxic chemotherapy
- No other concurrent cytotoxic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radionuclides
- No concurrent radionuclides
Surgery
- Not specified
Other
- At least 4 weeks since prior investigational agents
- No concurrent antiretroviral therapy for HIV-positive patients
- No concurrent participation in another investigational study
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1738
About this study
Official title: A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase III trial to determine the effectiveness of atrasentan in treating patients who have prostate cancer that has not responded to hormone therapy.
Read the detailed description
OBJECTIVES:
- Determine the safety of atrasentan in patients with hormone-refractory prostate cancer.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral atrasentan once daily for 3 years in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month and then every 3 months for 2 years.
PROJECTED ACCRUAL: Approximately 1,400 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- atrasentan hydrochloride
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atrasentan hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2002
- Primary 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 3
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gary Gordon, MD, PhD, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046943
- Sponsor's protocol ID
- CDR0000257127
- Other IDs
- ABBOTT-M00-258, UCLA-0202002, NCI-G02-2110
- Status last verified
- Sep 2003
- First submitted
- 3 Oct 2002
- Last updated
- 21 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00046943
- Acronym / sponsor ID
- CDR0000257127
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Jun 2007 (actual)
- First posted
- 27 Jan 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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase III trial to determine the effectiveness of atrasentan in treating patients who have prostate cancer that has not responded to hormone therapy.
Detailed description
OBJECTIVES:
- Determine the safety of atrasentan in patients with hormone-refractory prostate cancer.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral atrasentan once daily for 3 years in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month and then every 3 months for 2 years.
PROJECTED ACCRUAL: Approximately 1,400 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 hydrochloride | 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 21 Feb 2011.
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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, PhD
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing atrasentan hydrochloride in people with Prostate Cancer, run by Abbott at 1 site 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?
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 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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 21 Feb 2011.