Advanced Prostate AdenocarcinomaPhase 1AZD2171IL/0003NCT00502164
Study to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer
A Phase 1 study testing AZD2171 in people with Advanced Prostate Adenocarcinoma, run by AstraZeneca at 3 sites in United States.
Trial summary
A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Adenocarcinoma
- What is being tested?
- AZD2171
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2004to 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men, 18yrs and older
- Histological or cytological confirmation of prostate adenocarcinoma (symptomatic or asymptomatic)
- Prior hormonal therapy, and/or no more than 1 prior chemotherapy regimen (including estramustine and/or corticosteroids) for treatment of prostate adenocarcinoma
Who cannot join
- Prior radiotherapy to bone metastases within 4 weeks prior to screening
- any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy
- Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable with steroid treatment for 1 week.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Chicago, Illinois
Research Site
Nashville, Tennessee
Research Site
San Francisco, California
About this study
Official title: A Phase I Open-label Dose Escalation Study to Assess the Safety and Tolerability of AZD2171 Following Multiple Oral Doses in Subjects With Advanced Prostate Cancer.
A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced prostate cancer.
- Conditions
- Advanced Prostate Adenocarcinoma
- Being tested
- AZD2171
- Keywords
- Advanced Prostate Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2171Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma
Secondary outcomes (1)
Explore the PK profile of AZD2171 at steady-state administration to subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nick Botwood, BSc, MBBS, MRCP, MFPM, Study director, AstraZenecaEric Small, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502164
- Sponsor's protocol ID
- D8480C00003
- Acronym
- AZD2171IL/0003
- Status last verified
- Jan 2009
- First submitted
- 13 Jul 2007
- Last updated
- 21 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label Dose Escalation Study to Assess the Safety and Tolerability of AZD2171 Following Multiple Oral Doses in Subjects With Advanced Prostate Cancer.
- ClinicalTrials.gov ID
- NCT00502164
- Acronym / sponsor ID
- AZD2171IL/0003 / D8480C00003
- Conditions
- Advanced Prostate Adenocarcinoma
- Keywords
- Advanced Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- First posted
- 17 Jul 2007 (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.
A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced 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 (3 listed)
- Men, 18yrs and older
- Histological or cytological confirmation of prostate adenocarcinoma (symptomatic or asymptomatic)
- Prior hormonal therapy, and/or no more than 1 prior chemotherapy regimen (including estramustine and/or corticosteroids) for treatment of prostate adenocarcinoma
Key exclusion criteria (3 listed)
- Prior radiotherapy to bone metastases within 4 weeks prior to screening
- any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy
- Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable with steroid treatment for 1 week.
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 |
|---|---|---|
| AZD2171 | Drug | – |
Primary outcome
To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma
1 secondary outcome
Explore the PK profile of AZD2171 at steady-state administration to subjects
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 Jan 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.
Nick Botwood, BSc, MBBS, MRCP, MFPM study director
AstraZeneca
Eric Small, MD principal investigator
University of California, San Francisco
3 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 AZD2171 in people with Advanced Prostate Adenocarcinoma, run by AstraZeneca at 3 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 3 inclusion and 3 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 21 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does the primary outcome measure?
To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma. 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 21 Jan 2011.