Urothelial CancerPhase 2SPRUCENCT00578526
SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial
A Phase 2 study testing SU011248 in people with Urothelial Cancer and Bladder Cancer, run by AHS Cancer Control Alberta at 5 sites in Canada.
Trial summary
The purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer, Bladder Cancer, Adult
- What is being tested?
- SU011248
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 5 sitesCanada
- Study dates
- Apr 2008to 16 Jul 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically/cytologically proven inoperable, metastatic or recurrent transitional cell carcinoma of the urothelial tract
- Mixed histology with predominant TCC allowed.
- Failed, intolerant or ineligible for cisplatin based chemo
- Measurable Disease (RECIST)Not previously irradiated.
- Recovered from previous acute treatment to grade 1(CTCAE Vers. 3.0)
- No weight loss >/- 10% within 28 days of day 0
- Adequate Organ Function
Who cannot join
- Adenocarcinoma, squamous carcinoma or other histology without any components of transitional carcinoma.
- Small cell histology
- More than one previous systemic chemo
- Excised metastases without remaining measureable disease
- Prior therapy with angiogenesis inhibitors
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
London Health Sciences Centre
London, Ontario, T6A 4L6
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Randomized, Placebo-controlled Phase II Study to Compare the Efficacy and Safety of SU011248 Versus Placebo in Patients With Advanced Urothelial Transitional Cell Carcinoma Who Have Failed or Are Intolerant to Cisplatin-based Chemotherapy
The purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma.
Read the detailed description
The study objectives include the determination of the antitumor effect of SU011248 in patients with urothelial transitional cell carcinoma and to also determine the toxicities and tolerability of SU011248 in patients with urothelial transitional cell carcinoma who have failed or are intolerant to cisplatin-based chemotherapy.
The primary endpoint of the study is to compare progression free survival at 4 months in patients who received SU011248 plus BSC versus patients who received placebo plus BSC
The secondary endpoint is to compare the objective response rate and duration of response in patients who received SU011248 plus BSC versus patients who received placebo plus BSC, to describe the QOL and safety profile of SU011248 when compared to placebo and to describe the overall survival in patients who received SU011248 plus BSC versus patients who received placebo plus BSC
- Conditions
- Urothelial Cancer, Bladder Cancer, Adult
- Being tested
- SU011248, Placebo
- Keywords
- urothelial cancer, targeted therapy, antiangiogenesis therapy, SU011248, clinical trial
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SU011248Drug
Also called Sutent, Sunitinib
50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression
PlaceboDrug
50 mg capsule OD PO for 28 days then 14 days rest until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks Receives: Drug: SU011248 |
| Arm 2 | Placebo comparator | 1 50 mg capsule OD PO for 4 weeks with 2 week rest until disease progression. Any patient with disease progression will be unblinded and patients on the placebo arm may then be considered for the open label Sutent treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 4 months
Secondary outcomes (5)
objective response rate
Measured: Study Duration
duration of response
Measured: study duration
Change in health-related quality of life
Measured: Study Duration
Number of participants that develop an adverse event to treatment.
Measured: Study Duration
Overall Survival
Measured: Study Duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startApr 2008
- Primary completion16 Jul 2014
- Study completion16 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Tina Cheng, AHS Cancer Control Alberta
- Investigators
- Tina Cheng, M.D., Study director, Tom Baker Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578526
- Sponsor's protocol ID
- SPRUCE02
- Acronym
- SPRUCE
- Status last verified
- Aug 2018
- First submitted
- 19 Dec 2007
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Phase II Study to Compare the Efficacy and Safety of SU011248 Versus Placebo in Patients With Advanced Urothelial Transitional Cell Carcinoma Who Have Failed or Are Intolerant to Cisplatin-based Chemotherapy
- ClinicalTrials.gov ID
- NCT00578526
- Acronym / sponsor ID
- SPRUCE / SPRUCE02
- Conditions
- Urothelial Cancer, Bladder Cancer, Adult
- Keywords
- urothelial cancer, targeted therapy, antiangiogenesis therapy, SU011248, clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2008
- Primary completion
- 16 Jul 2014 (actual)
- Study completion
- 16 Jul 2014 (actual)
- First posted
- 21 Dec 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 purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma.
Detailed description
The study objectives include the determination of the antitumor effect of SU011248 in patients with urothelial transitional cell carcinoma and to also determine the toxicities and tolerability of SU011248 in patients with urothelial transitional cell carcinoma who have failed or are intolerant to cisplatin-based chemotherapy.
The primary endpoint of the study is to compare progression free survival at 4 months in patients who received SU011248 plus BSC versus patients who received placebo plus BSC
The secondary endpoint is to compare the objective response rate and duration of response in patients who received SU011248 plus BSC versus patients who received placebo plus BSC, to describe the QOL and safety profile of SU011248 when compared to placebo and to describe the overall survival in patients who received SU011248 plus BSC versus patients who received placebo plus BSC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: SU011248SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks |
| Arm 2 | Placebo comparator | Drug: Placebo1 50 mg capsule OD PO for 4 weeks with 2 week rest until disease progression. Any patient with disease progression will be unblinded and patients on the placebo arm may then be considered for the open label Sutent treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically/cytologically proven inoperable, metastatic or recurrent transitional cell carcinoma of the urothelial tract
- Mixed histology with predominant TCC allowed.
- Failed, intolerant or ineligible for cisplatin based chemo
- Measurable Disease (RECIST)Not previously irradiated.
- Recovered from previous acute treatment to grade 1(CTCAE Vers. 3.0)
Key exclusion criteria (5 listed)
- Adenocarcinoma, squamous carcinoma or other histology without any components of transitional carcinoma.
- Small cell histology
- More than one previous systemic chemo
- Excised metastases without remaining measureable disease
- Prior therapy with angiogenesis inhibitors
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 |
|---|---|---|
| SU011248Also: Sutent, Sunitinib50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression | Drug | Arm 1 |
| Placebo50 mg capsule OD PO for 28 days then 14 days rest until disease progression | Drug | Arm 2 |
Primary outcome
Progression Free Survival
Time frame: 4 months
5 secondary outcomes
objective response rate
Time frame: Study Duration
duration of response
Time frame: study duration
Change in health-related quality of life
Time frame: Study Duration
Number of participants that develop an adverse event to treatment.
Time frame: Study Duration
Overall Survival
Time frame: Study Duration
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 22 Aug 2018.
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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.
Tina Cheng, M.D. study director
Tom Baker Cancer Centre
5 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 SU011248 in people with Urothelial Cancer and Bladder Cancer, run by AHS Cancer Control Alberta at 5 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 7 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: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. Some participants in this study may receive a placebo. 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?
Progression Free Survival (time frame: 4 months). 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 22 Aug 2018.