Prostate CancerPhase 2SMARTNCT00550810
Sutent Maintenance After Response to Taxotere
A Phase 2 study testing Sunitinib (SU011248) in people with Prostate Cancer and Hormone Refractory, run by Alberta Health services at 4 sites in Canada.
Trial summary
The major goal is to determine whether the experimental agent has clinically promising activity that would merit progression to a formal phase III trial. Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no systemic treatment has been proven to be… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Hormone Refractory
- What is being tested?
- Sunitinib (SU011248)
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 4 sitesCanada
- Study dates
- Oct 2007to Nov 2012
- 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
- Histological or cytological diagnosis of adenocarcinoma of the prostate
- Metastatic or locally recurrent disease not curable with standard therapy
- ECOG performance status 0, 1 or 2
- Prior single agent docetaxel or docetaxel combination chemotherapy with a documented PSA or imaging response, and no objective evidence of disease progression at study enrolment
Who cannot join
- Patients with a history of other invasive cancer, except adequately treated non
- melanoma skin cancer.
- Patients with known brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to SU011248.
- Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Tom Baker Cancer Centre
Calgary, Alberta, t4c 2h5
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
London Health Sciences Centre
London, Ontario, N6A 4L6
Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy
The major goal is to determine whether the experimental agent has clinically promising activity that would merit progression to a formal phase III trial.
Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no systemic treatment has been proven to be effective. Because of its action, safety and simple administration SU011248 has potential for effectiveness in this disease setting. Promising activity in this study would provide the necessary proof-of-principle for a larger confirmatory study in this population, and potentially in earlier stages of this common disease.
- Conditions
- Prostate Cancer, Hormone Refractory
- Being tested
- Sunitinib (SU011248)
- Keywords
- Sutent
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunitinib (SU011248)Drug
Also called Sutent
SU011248 (study medication) will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2 week rest period to form a complete cycle of 6 weeks. Study medication will be orally self administered once daily without regard to meals beginning on Day 1 of the study. Cycles will be repeated in the absence of unacceptable toxicity or disease progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 180 days without evidence of disease progression would be considered clinically worthy of further investigation
Secondary outcomes (1)
-PSA Response -Toxicity
Measured: The secondary endpoint of PSA response will also be documented. PSA response is defined as a ≥50% fall in PSA (minimum of 5 µg/L) from baseline maintained for > 3 weeks and without evidence of disease progression otherwise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startOct 2007
- Study completionNov 2012 (estimated)
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Rachel Syme, Alberta Health services
- Investigators
- Bernhard Eigl, M.D., Study chair, Tom Baker Cancer Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550810
- Sponsor's protocol ID
- TBCC-0707001
- Other IDs
- SMART
- Acronym
- SMART
- Status last verified
- Sep 2011
- First submitted
- 26 Oct 2007
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy
- ClinicalTrials.gov ID
- NCT00550810
- Acronym / sponsor ID
- SMART / TBCC-0707001
- Conditions
- Prostate Cancer, Hormone Refractory
- Keywords
- Sutent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2007
- Study completion
- Nov 2012 (estimated)
- First posted
- 30 Oct 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.
The major goal is to determine whether the experimental agent has clinically promising activity that would merit progression to a formal phase III trial.
Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no systemic treatment has been proven to be effective. Because of its action, safety and simple administration SU011248 has potential for effectiveness in this disease setting. Promising activity in this study would provide the necessary proof-of-principle for a larger confirmatory study in this population, and potentially in earlier stages of this common disease.
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 (4 listed)
- Histological or cytological diagnosis of adenocarcinoma of the prostate
- Metastatic or locally recurrent disease not curable with standard therapy
- ECOG performance status 0, 1 or 2
- Prior single agent docetaxel or docetaxel combination chemotherapy with a documented PSA or imaging response, and no objective evidence of disease progression at study enrolment
Key exclusion criteria (5 listed)
- Patients with a history of other invasive cancer, except adequately treated non
- melanoma skin cancer.
- Patients with known brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to SU011248.
- Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment.
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 |
|---|---|---|
| Sunitinib (SU011248)Also: SutentSU011248 (study medication) will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2 week rest period to form a complete cycle of 6 weeks. Study medication will be orally self administered once daily without regard to meals beginning on Day 1 of the study. Cycles will be repeated in the absence of unacceptable toxicity or disease progression | Drug | – |
Primary outcome
Progression Free Survival
Time frame: 180 days without evidence of disease progression would be considered clinically worthy of further investigation
1 secondary outcome
-PSA Response -Toxicity
Time frame: The secondary endpoint of PSA response will also be documented. PSA response is defined as a ≥50% fall in PSA (minimum of 5 µg/L) from baseline maintained for > 3 weeks and without evidence of disease progression otherwise.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 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.
Bernhard Eigl, M.D. study chair
Tom Baker Cancer Board
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib (SU011248) in people with Prostate Cancer and Hormone Refractory, run by Alberta Health services at 4 sites in Canada.
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 4 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 7 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in 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.
What does the primary outcome measure?
Progression Free Survival (time frame: 180 days without evidence of disease progression would be considered clinically worthy of further investigation). 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 7 Dec 2011.