Bladder CancerPhase 3NCT01469221
Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)
A Phase 3 study testing Apaziquone in people with Bladder Cancer, run by Spectrum Pharmaceuticals, Inc at 29 sites in 4 countries.
Trial summary
This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Apaziquone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 29 sitesin 4 countries
- Study dates
- Jan 2012to Apr 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Has the patient given written informed consent and is the patient willing and able to abide by the protocol?
- Is the patient 18 years old or above?
- If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
- Does the female patient of childbearing potential have a negative serum pregnancy test at screening?
- Does the patient with clinically apparent primary or recurrent low grade Ta NMIBC have :
- multiple tumors (2-7)
Show all 16Show fewer
- No single Tumor > 3 cm
- No history / evidence of Tis
- Or does the patient with clinically apparent primary or recurrent high grade Ta NMIBC have:
- A single tumor that is ≤ 3 cm
- No history / evidence of Tis
- Is the patient able to retain bladder instillations for a minimum of 60 minutes (± 6 minutes)?
- Did the patient have upper urinary tract evaluation to exclude urothelial carcinoma, hydronephrosis or renal cell carcinoma or other renal cancers in the 6 months prior to study screening?
- Is patient's urethra (including prostatic urethra in men) endoscopically free of any visible TCC?
- For patients with recurrent tumor, did the patient have at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and the time of screening?
- Has the male patient with a prostate specific antigen (PSA) between 4 and 10 ng/mL had a diagnostic evaluation that reasonably excludes the diagnosis of prostate cancer in the opinion of the Investigator?
Who cannot join
- Has the patient received any previous pelvic radiotherapy (includes external beam and/or brachytherapy)?
- Has the patient ever received apaziquone?
- Has the patient received an induction course (completed 5 of 6 scheduled weekly instillations) of intravesical BCG (± interferon) with the last dose given less than 12 months ago?
- Has the patient had any prior intravesical chemotherapy, exclusive of single-dose adjuvant intravesical chemotherapy immediately post-TURBT?
- Does the patient have a history of urinary retention or a post void residual ≥ 250 cc by bladder scan or ultrasound (post void residual test may be repeated up to 3 times)?
- Does the patient have or has the patient had any bladder tumor with histology other than transitional cell carcinoma?
Show all 30Show fewer
- Does the patient have or has the patient had micro-papillary transitional cell carcinoma?
- If the patient has recurrent papillary disease of the bladder, has the pathology been anything other than pTa in the past?
- Does the patient have an active urinary tract infection confirmed by culture or a documented history of recurrent UTI (≥ 6 for females and ≥2 for males per year) in the prior 2 years?
- Does the patient have a bleeding disorder or a screening platelet count < 50 x 109/L?
- Does the patient have a screening hemoglobin < 10 g/dL?
- Does the male patient have a screening serum PSA > 10 ng/mL?
- Does the patient have a history of Acquired Immunodeficiency Syndrome or HIV positive?
- Does the patient have a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g., uncontrolled diabetes, decompensated congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, or an active uncontrolled infection), which could compromise participation, compliance with scheduled visits and/or completion of the study?
- Has the patient participated in an investigational protocol within the past 90 days?
- Is the patient pregnant or breast feeding?
- Does the patient have a life expectancy of <3 years?
- Has the patient had any other malignancy or received therapy for any malignancy in the last five years except
- non-melanoma skin tumors
- stage 0 (in situ) cervical carcinoma
- undetectable PSA for ≥1 year following definitive therapy for localized prostate cancer?
- Does the patient have documented vesicoureteral reflux or an indwelling ureteral stent?
- Does the patient have tumor in a bladder diverticulum?
- Does the patient have a known allergy to red color food dye?
- Double-Blind Phase Inclusion Criteria
- Was all visible tumor resected at the initial TURBT?
- Does Central Pathology review of the patient's bladder tumor confirm:
- Low grade Ta disease for multiple tumors (2 - 7) or
- High Grade Ta disease for single tumor
- No microscopic evidence of lymphovascular invasion and/or evidence of tumor thromboemboli
Trial locations and contacts
29 sites in 4 countries.
29 sites in 4 countries
Poland16 sites
Szpital Miejski im. Prof. E. Michałowskiego
Katowice, 40-073
CenterMed Kraków sp z o.o.
Krakow, 31-530
Niepubliczny Zakład Opieki Zdrowotnej-Centrum Medyczne Szpital Świętej Rodziny sp z o.o.
Lodz, 90-302
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lublinie, Oddział Urologii i Onkologii Urologicznej
Lublin, 20-718
Nieubliczny Zakład Opieki Zdrowotnej Europejskie Centrum Zdrowia Otwock im. Fryderyka Chopina Nieubliczny Zakład Opieki Zdrowotnej
Otwock, 05-400
Niepubliczny Zakład Opieki Zdrowotnej Pabianickie Centrum Medyczne
Pabianice, 95-200
Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3
Rybnik, 44-200
Wojewódzki Szpital Specjalistyczny W Siedlcach
Siedlce, 08-110
Wojewódzki Szpital Specjalistyczny im Janusza Korczaka
Słupsk, 76-200
Pomorska Akademia Medyczna
Szczecin, 70-111
Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
Warsaw, 00-416
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON
Warsaw, 00-909
Szpital Bielański im. ks. J. Popiełuszki Samodzielny Publiczny Zakład Opieki Zdrowotnej
Warsaw, 01-809
Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń
Warsaw, 02-005
Międzyleski Szpital Specjalistyczny w Warszawie Oddział Urologii
Warsaw, 04-749
Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy
Wroclaw, 51-124
United States7 sites
Alliance Urology Specialists
Greensboro, North Carolina, 27403
Tower Research Institute
Los Angeles, California, 90048
Department of Urology, University of Miami Miller School of Medicine
Miami, Florida, 33136
Associated Medical Professionals of New York, PLLC
Oneida, New York, 13421
Somerset Urological Associates, PA
Somerville, New Jersey, 08876
Male and Female Urology
Staten Island, New York, 10314
Associated Medical Professionals of New York, PLLC
Syracuse, New York, 13210
Slovakia4 sites
Univerzitná nemocnica L. Pasteura Košice Univerzitná nemocnica L. Pasteura Košice
Košice, 041 66
Univerzitná nemocnica Martin Urologická klinika
Martin, 036 59
Fakultná nemocnica s poliklinikou J. A. Reimana Prešov Urologická klinika
Prešov, 081 81
Fakultná nemocnica s poliklinikou Žilina Urologické oddelenie
Žilina, 012 07
Czechia2 sites
Nemocnice Jablonec nad Nisou, Urologické oddělení
Jablonec nad Nisou, 466 60
Fakultní Thomayerova nemocnice s poliklinikou Urologické oddělení
Prague, 14059
About this study
Official title: A Phase 3 International, Double-Bind Trial Evaluating Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)
This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double Blind Phase qualification, patients with confirmed eligibility will be randomized to receive either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo cystoscopic and safety assessments every 3 months for 24 months. Patients with histologic evidence of recurrent disease during the study will be treated according to current treatment guidelines or local standard of care. Safety and efficacy assessments will be performed at 3 month intervals for all randomized patients throughout the study. Patients who receive single dose of apaziquone immediately following TURBT and are not eligible for randomization will be followed for 3 months by cystoscopic exam and safety assessments.
- Conditions
- Bladder Cancer
- Being tested
- Apaziquone, Placebo
- Keywords
- Bladder Cancer, Non-Muscle Invasive Bladder Cancer, NMIBC, Apaziquone, EOquin, GU Cancer, TURBT
- 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.
ApaziquoneDrug
Also called EoQuin, EO9
6 weekly multi-instillation of Apaziquone 4 mg in 40 mL
PlaceboDrug
6 weekly multi-instillation of matching placebo in 40mL
| Study group | Role | What they receive |
|---|---|---|
| Apaziquone | Experimental | Apaziquone (4 mg in 40 mL) Receives: Drug: Apaziquone |
| Placebo | Placebo comparator | Matching placebo (40 mL) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recurrence
Time from randomization to the date of first histologically confirmed recurrence of bladder cancer
Measured: 24 Months
Secondary outcomes (1)
2-Year Recurrence Rate
Proportion of patients with recurrence at or before 24 months
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Business reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Show-Li Sun, MD, Study director, Spectrum Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469221
- Sponsor's protocol ID
- SPI-1012
- Other IDs
- 2011-003517-42
- Status last verified
- Oct 2017
- First submitted
- 8 Nov 2011
- Last updated
- 15 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 International, Double-Bind Trial Evaluating Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)
- ClinicalTrials.gov ID
- NCT01469221
- Acronym / sponsor ID
- SPI-1012
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Non-Muscle Invasive Bladder Cancer, NMIBC, Apaziquone, EOquin, GU Cancer, TURBT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reason
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Allergan
- Study start
- Jan 2012 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Posted 15 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double Blind Phase qualification, patients with confirmed eligibility will be randomized to receive either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo cystoscopic and safety assessments every 3 months for 24 months. Patients with histologic evidence of recurrent disease during the study will be treated according to current treatment guidelines or local standard of care. Safety and efficacy assessments will be performed at 3 month intervals for all randomized patients throughout the study. Patients who receive single dose of apaziquone immediately following TURBT and are not eligible for randomization will be followed for 3 months by cystoscopic exam and safety assessments.
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 |
|---|---|---|
| Apaziquone | Experimental | Drug: ApaziquoneApaziquone (4 mg in 40 mL) |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo (40 mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Has the patient given written informed consent and is the patient willing and able to abide by the protocol?
- Is the patient 18 years old or above?
- If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
- Does the female patient of childbearing potential have a negative serum pregnancy test at screening?
- Does the patient with clinically apparent primary or recurrent low grade Ta NMIBC have :
Key exclusion criteria (30 listed)
- Has the patient received any previous pelvic radiotherapy (includes external beam and/or brachytherapy)?
- Has the patient ever received apaziquone?
- Has the patient received an induction course (completed 5 of 6 scheduled weekly instillations) of intravesical BCG (± interferon) with the last dose given less than 12 months ago?
- Has the patient had any prior intravesical chemotherapy, exclusive of single-dose adjuvant intravesical chemotherapy immediately post-TURBT?
- Does the patient have a history of urinary retention or a post void residual ≥ 250 cc by bladder scan or ultrasound (post void residual test may be repeated up to 3 times)?
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 |
|---|---|---|
| ApaziquoneAlso: EoQuin, EO96 weekly multi-instillation of Apaziquone 4 mg in 40 mL | Drug | Apaziquone |
| Placebo6 weekly multi-instillation of matching placebo in 40mL | Drug | Placebo |
Primary outcome
Time to Recurrence
Time frame: 24 Months
Time from randomization to the date of first histologically confirmed recurrence of bladder cancer
1 secondary outcome
2-Year Recurrence Rate
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Show-Li Sun, MD study director
Spectrum Pharmaceuticals, Inc
29 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apaziquone in people with Bladder Cancer, run by Spectrum Pharmaceuticals, Inc at 29 sites in 4 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 16 inclusion and 30 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 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Poland, United States, Slovakia, Czechia. 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 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?
Yes. Results are posted in the registry (first posted 15 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Recurrence (time frame: 24 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 15 Dec 2017.