Bladder CancerPhase 2/3NCT01475266
Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
A Phase 2/3 study testing EO9 (Apaziquone) in people with Bladder Cancer, run by Nippon Kayaku Co., Ltd. at 20 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- EO9 (Apaziquone)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Nov 2011to Apr 2013
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have provided written informed consent
- Patients who have urothelial cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2 and satisfy both of the following criteria:
- The maximum number of tumors is 5.
- Each tumor diameter: ≤ 3.5 cm.
- Age: ≥20 years old at enrollment.
- The functions of the major organs are adequate, and the following test value criteria are satisfied:
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- Neutrophil count ≥1,500/μL
- Platelet count ≥10×10^4/μL
- Hemoglobin ≥10 g/dL
Who cannot join
- Patients with a single, primary bladder cancer of <0.5 cm.
- Patients with CIS lesions in the bladder or a history thereof.
- Patients with a history of other than stage Ta, histological grade G1 or G2 disease.
- Patients experiencing recurrence within 4 months following TURBT for prior NMIBC (duration between the last TURBT and cystoscopic confirmation of the present recurrence is within 4 months).
- Patients without at least a three-month cystoscopically confirmed recurrence-free interval between the last TURBT and the time of study screening
- Patients having a bladder tumor with a histological diagnosis other than urothelial carcinoma of the bladder or a history thereof.
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- Patients who had been administered EO9 in the past.
- Patients who had been administered any other investigational drug within the past 30 days.
- Patients having a medical condition that would make it unsafe for them to undergo TURBT under general or spinal anesthesia.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
Japan11 sites
Nippon kayaku Investigational site 101
Chiba
Nippon Kayaku Investigational site 110
Fukuoka
Nippon Kayaku Investigational site 111
Fukuoka
Nippon Kayaku Investigational site 104
Hamamatsu, Shizuoka
Nippon Kayaku Investigational site 107
Kashihara, Nara
Nippon Kayaku Investigational site 109
Kurashiki, Okayama-ken
Nippon Kayaku Investigational site 102
Musashino, Tokyo
Nippon Kayaku Investigational site 106
Nara
Nippon Kayaku Investigational site 108
Okayama
Nippon Kayaku Investigational site 105
Sayama, Osaka
Nippon Kayaku Investigational site 103
Yokosuka, Kanagawa
South Korea9 sites
Handok Investigational site 203
Bundang
Handok Investigational site 202
Daegu
Handok Investigational site 209
Hwasun
Handok Investigational site 201
Seoul
Handok Investigational site 204
Seoul
Handok Investigational site 205
Seoul
Handok Investigational site 206
Seoul
Handok Investigational site 207
Seoul
Handok Investigational site 208
Yangsan
About this study
Official title: Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC
The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT.
- Conditions
- Bladder Cancer
- Being tested
- EO9 (Apaziquone), Placebo
- Keywords
- Bladder Cancer, NMIBC, TURBT, Apaziquone, EOquin, Immediate instillation
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EO9 (Apaziquone)Drug
Also called Eoquin(R)
4 mg/40 mL, Intravesical instillation, Single dose within 6 hours after TURBT
PlaceboDrug
40 mL, Intravesical instillation, Single dose within 6 hours after TURBT
| Study group | Role | What they receive |
|---|---|---|
| EO9 (Apaziquone) | Experimental | Not described Receives: Drug: EO9 (Apaziquone) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer
Measured: 2 years
Secondary outcomes (7)
The recurrence-free interval in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer
Measured: 2 years
The progression rate
Measured: 2 years
The number of recurrences per patient
Measured: 2 years
The progression-free survival period
Measured: 2 years
The recurrence-free survival period
Measured: 2 years
The overall survival period
Measured: 2 years
The safety of EO9
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nippon Kayaku Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Handok Inc.
- Responsible party
- Sponsor
- Investigators
- Yoshihiro Nambu, M.D., Ph.D., Study director, Nippon Kayaku Co., Ltd.Woo Ick Jang, M.D., Ph.D., Study director, Handok Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475266
- Sponsor's protocol ID
- A9EO9201
- Other IDs
- EO9_C301
- Status last verified
- Apr 2013
- First submitted
- 16 Nov 2011
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC
- ClinicalTrials.gov ID
- NCT01475266
- Acronym / sponsor ID
- A9EO9201
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, NMIBC, TURBT, Apaziquone, EOquin, Immediate instillation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Nippon Kayaku Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Handok Inc.
- Study start
- Nov 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Nov 2011 (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 evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EO9 (Apaziquone) | Experimental | Drug: EO9 (Apaziquone) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who have provided written informed consent
- Patients who have urothelial cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2 and satisfy both of the following criteria:
- Age: ≥20 years old at enrollment.
- The functions of the major organs are adequate, and the following test value criteria are satisfied:
Key exclusion criteria (9 listed)
- Patients with a single, primary bladder cancer of <0.5 cm.
- Patients with CIS lesions in the bladder or a history thereof.
- Patients with a history of other than stage Ta, histological grade G1 or G2 disease.
- Patients experiencing recurrence within 4 months following TURBT for prior NMIBC (duration between the last TURBT and cystoscopic confirmation of the present recurrence is within 4 months).
- Patients without at least a three-month cystoscopically confirmed recurrence-free interval between the last TURBT and the time of study screening
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 |
|---|---|---|
| EO9 (Apaziquone)Also: Eoquin(R)4 mg/40 mL, Intravesical instillation, Single dose within 6 hours after TURBT | Drug | EO9 (Apaziquone) |
| Placebo40 mL, Intravesical instillation, Single dose within 6 hours after TURBT | Drug | Placebo |
Primary outcome
The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer
Time frame: 2 years
7 secondary outcomes
The recurrence-free interval in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer
Time frame: 2 years
The progression rate
Time frame: 2 years
The number of recurrences per patient
Time frame: 2 years
The progression-free survival period
Time frame: 2 years
The recurrence-free survival period
Time frame: 2 years
The overall survival period
Time frame: 2 years
The safety of EO9
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
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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.
Yoshihiro Nambu, M.D., Ph.D. study director
Nippon Kayaku Co., Ltd.
Woo Ick Jang, M.D., Ph.D. study director
Handok Inc.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EO9 (Apaziquone) in people with Bladder Cancer, run by Nippon Kayaku Co., Ltd. at 20 sites in 2 countries.
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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan, South Korea. 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 combined 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.
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 was stopped early (reason given: Sponsor's decision). 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?
The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer (time frame: 2 years). 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 29 Mar 2017.