Prostate CancerPhase 2NCT00241475
Gefitinib in the Treatment of the First Relapse of Prostate Cancer Beyond Prostatectomy or Radiotherapy
A Phase 2 study testing Gefitinib in people with Prostate Cancer, run by AstraZeneca at 1 site in Finland.
Trial summary
To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Gefitinib
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2003to Oct 2005
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed prostate cancer after prostatectomy or radiotherapy
- PSA levels below 10 ng/mL
- Lymph node negative
- Metastasis negative
- Withdrawal of hormone therapy at least 6 months before entry into the study
- Written informed consent
Who cannot join
- Metastatic disease
- Hormonal treatment 6 months before study entry
- Concomitant radiotherapy, surgery and/or chemotherapy
- ILD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Non-Comparative, Phase II Study of ZD1839 (Iressa) as First-Line Treatment in Subjects With Relapsed Prostate Cancer Following Radical Prostatectomy or Radiotherapy
To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure
- Conditions
- Prostate Cancer
- Being tested
- Gefitinib
- Keywords
- Cancer of the Prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA response rate at statistical study closure based on the percentage of subjects experiencing PSA normalization or a > 50% reduction in PSA levels compared with study entry sustained for 3 months (i.e. three consecutive measurements)
Secondary outcomes (3)
TTF (failure defined as a need for additional/alternative therapy due to PSA progression, metastases or AEs)
Duration of PSA response
PFS (progression defined as doubling in PSA levels compared with the PSA level at study entry)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startDec 2003
- Study completionOct 2005
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Finland Medical Director, MD, Study director, AstraZeneca Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241475
- Sponsor's protocol ID
- 1839IL/0155
- Status last verified
- Apr 2009
- First submitted
- 18 Oct 2005
- Last updated
- 23 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Non-Comparative, Phase II Study of ZD1839 (Iressa) as First-Line Treatment in Subjects With Relapsed Prostate Cancer Following Radical Prostatectomy or Radiotherapy
- ClinicalTrials.gov ID
- NCT00241475
- Acronym / sponsor ID
- 1839IL/0155
- Conditions
- Prostate Cancer
- Keywords
- Cancer of the Prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- Oct 2005 (actual)
- First posted
- 19 Oct 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.
To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure
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 (6 listed)
- Relapsed prostate cancer after prostatectomy or radiotherapy
- PSA levels below 10 ng/mL
- Lymph node negative
- Metastasis negative
- Withdrawal of hormone therapy at least 6 months before entry into the study
Key exclusion criteria (4 listed)
- Metastatic disease
- Hormonal treatment 6 months before study entry
- Concomitant radiotherapy, surgery and/or chemotherapy
- ILD
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 |
|---|---|---|
| Gefitinib | Drug | – |
Primary outcome
PSA response rate at statistical study closure based on the percentage of subjects experiencing PSA normalization or a > 50% reduction in PSA levels compared with study entry sustained for 3 months (i.e. three consecutive measurements)
3 secondary outcomes
TTF (failure defined as a need for additional/alternative therapy due to PSA progression, metastases or AEs)
Duration of PSA response
PFS (progression defined as doubling in PSA levels compared with the PSA level at study entry)
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 23 Apr 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.
AstraZeneca Finland Medical Director, MD study director
AstraZeneca Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefitinib in people with Prostate Cancer, run by AstraZeneca at 1 site in Finland.
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 6 inclusion and 4 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 23 Apr 2009. 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 Finland. 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?
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?
PSA response rate at statistical study closure based on the percentage of subjects experiencing PSA normalization or a > 50% reduction in PSA levels compared with study entry sustained for 3 months (i.e. three consecutive measurements). 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 23 Apr 2009.