Bladder CancerPhase 3NCT02563561
A Study of Intravesical Apaziquone as a Surgical Adjuvant in Participant Undergoing Transurethral Resection Bladder Tumor (TURBT)
A Phase 3 study testing Apaziquone in people with Bladder Cancer, run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder cancer (NMIBC), ≤3.5 centimeters (cm) in diameter, all of which must had been fully resected at 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
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2015to 10 Mar 2017
- 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
None listed.
Who cannot join
- Participant had an active concurrent malignancy/life-threatening disease. If there was a history of prior malignancies/life-threatening diseases, the participant was to be disease-free for at least 5 years. Participant with other prior malignancies less than 5 years before study entry could have still been enrolled if they had received treatment resulting in complete resolution of the cancer and currently had no clinical, radiologic, or laboratory evidence of active or recurrent disease.
- Participant had positive urine cytology for malignancy at Screening.
- Participant had an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the participant to receive protocol treatment.
- Participant had used any investigational drugs, biologics, or devices within 30 days prior to study treatment or planned to use any of these during the course of the study.
- Participant had any prior intravesical chemotherapy, immunotherapy, or previous exposure to apaziquone.
- Participant had or has ever had
Show all 21Show fewer
- Upper tract Transitional Cell Carcinoma (TCC).
- Urethral tumor (prostatic urethra included).
- Any invasive bladder tumor known to be other than tumor Ta, G1-G2.
- Any evidence of lymph node or distant metastasis.
- Any bladder tumor with histology other than TCC.
- Carcinoma in situ (CIS).
- Participant had a tumor in a bladder diverticulum.
- Participant had received any pelvic radiotherapy (including external beam and/or brachytherapy.)
- Participant had a bleeding disorder or a screening platelet count <100×10^9/L.
- Participant had screening hemoglobin <10 milligrams per deciliter (mg/dL).
- Participant had any unstable medical condition that would make it unsafe to undergo TURBT.
- Participant had a history of interstitial cystitis.
- Participant had a history of allergy to red color food dye.
- For a participant with a recurrent tumor, the participant had at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and screening cystoscopic examination.
- Participant was pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Urology Center of Colorado
Denver, Colorado, 80211
About this study
Official title: A Multicenter, Multi-Arm, Randomized, Multi-Dose, Placebo-Controlled, Double-Blind, Phase 3 Study of Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant in the Immediate Postoperative Period in Patients Undergoing Transurethral Resection for Non- Muscle Invasive Bladder Cancer
This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder cancer (NMIBC), ≤3.5 centimeters (cm) in diameter, all of which must had been fully resected at TURBT.
In addition to Screening, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.
Read more
Following TURBT on Day 1, eligible participants were randomized to one of three treatment arms in a 1:1:1 ratio.
Arm 1 : One dose of Apaziquone. Arm 2 : Two Doses of Apaziquone. Arm 3 : Placebo. Primary endpoint was to evaluate the Time to Recurrence with either a one instillation of 4 mg apaziquone or two instillations of 4 milligram (mg) apaziquone relative to placebo instillation following TURBT in a participant with NMIBC who received TURBT.
Read the detailed description
This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder tumors, ≤3.5 cm in diameter, all of which must have been fully resected at TURBT.
In addition to Screening, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.
Following TURBT on Day 1, eligible participants were randomized to one of three treatment arms in a 1:1:1 ratio :
Arm 1 : One Dose of Apaziquone:
- Day 1: administration of 4 mg of apaziquone 60±30 minutes post-TURBT
- Day 15 (±5 days): administration of placebo
Arm 2 : Two Doses of Apaziquone :
- Day 1: administration of 4 mg of apaziquone 60±30 minutes post-TURBT
- Day 15 (±5 days): administration of 4 mg of apaziquone
Arm 3: Placebo :
- Day 1 : administration of placebo 60±30 minutes post-TURBT
- Day 15 (±5 days) : administration of placebo
Once randomized, Day 1 study drug instillation occurred 60 ±30 minutes post TURBT. Participants returned on Day 15 (±5 days) for a second instillation unless their pathology results showed non Ta, G1-G2 histology; in the absence of local pathology results by the Day 15 visit, participants received a second instillation of study drug. All histology specimens were reviewed by a local pathology laboratory and all clinical treatment decisions and study analyses were based on the local pathology review. Participants whose pathology was other than Ta, G1-G2 were followed for safety at Day 35 (±5 days) from the last dose of study drug and then discontinued from the study.
Participants with pathology confirmed Ta, G1-G2 disease were followed according to the schedule below :
- Cystoscopic examination and urine cytology every 90 days (±10 days) (calculated from date of TURBT) through 24 months for tumor recurrence and progression.
- If at any time during the 24 months follow up period there was a tumor recurrence, the participant continued on study with follow-up cystoscopic examination and urine cytology every 90 days (±10 days) (calculated from date of TURBT) through the end of 24 months. Participants with a recurrence were permitted to have a follow-up TURBT.
- If at any time during the 24 months follow up period there was a tumor recurrence and/or participant started on another therapy, the participant was followed by telephone, for safety every 90 days (±10 days) (calculated from date of TURBT) through the end of 24 months.
Duration of Study: The duration of the study for each participant was approximately 24 months including:
- Screening Period : 30-days
- Treatment Period : Day 1 and Day 15 (±5 days)
- Safety and Follow-up Period: 24-months
- Conditions
- Bladder Cancer
- Being tested
- Apaziquone, Placebo
- Keywords
- Bladder Cancer, Non-muscle invasive bladder cancer, Apaziquone, TURBT, Stage Ta, G1-G2
- 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
One dose of apaziquone administered by intravesical administration
PlaceboOther
Matching placebo (containing 12 mg FD\&C red #40, 15 mg sodium chloride, and 10 mg mannitol was supplied in identical appearing vials) by intravesical administration.
| Study group | Role | What they receive |
|---|---|---|
| 1 Dose Apaziquone | Experimental | Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post transurethral resection of bladder tumor (TURBT) on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days). Receives: Drug: Apaziquone; Other: Placebo |
| 2 Dose Apaziquone | Experimental | Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of 4 mg of apaziquone by intravesical administration via an indwelling catheter on Day 15 (±5 days). Receives: Drug: Apaziquone |
| Placebo | Placebo comparator | Participants were randomized to receive first dose of matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of matching placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days). Receives: Other: 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 histologically confirmed recurrence of bladder cancer. A recurrence was defined as any pathologically confirmed disease of ≥Ta tumor histology or carcinoma in situ (CIS) post-treatment.
Measured: From randomization to the date of first histologically confirmed recurrence of bladder cancer (up to 1.5 years)
Secondary outcomes (4)
2-Year Recurrence Rate
The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before Year 2. A recurrence was defined as any pathologically confirmed disease of ≥Ta tumor histology or CIS post-treatment.
Measured: 2 years
1-Year Recurrence Rate
The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before Year 1. A recurrence was defined as any pathologically confirmed disease of ≥Ta tumor histology or CIS post-treatment.
Measured: 1 year
Time to Progression
Time to disease progression was defined as the time from randomization to the first disease progression. The development of T2 or greater disease was only included in the assessment of time to disease progression.
Measured: From randomization to the date of first disease progression (up to 1.5 years)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. TEAEs were adverse events that occurred from the first dose of study treatment until 40 days after the last dose of study drug administration or 40 days after the date of participant early discontinuation. Treatment-related AEs included TEAEs with relationship to study treatment reported as possible, probable, definite, or missing. An SAE was an AE resulting in any of the outcomes: death; initial/prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to 1.5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study start9 Oct 2015
- Primary completion10 Mar 2017
- Study completion10 Mar 2017
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563561
- Sponsor's protocol ID
- SPI-EOQ-13-305
- Status last verified
- Oct 2021
- First submitted
- 21 Sep 2015
- Last updated
- 27 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multi-Arm, Randomized, Multi-Dose, Placebo-Controlled, Double-Blind, Phase 3 Study of Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant in the Immediate Postoperative Period in Patients Undergoing Transurethral Resection for Non- Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT02563561
- Acronym / sponsor ID
- SPI-EOQ-13-305
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Non-muscle invasive bladder cancer, Apaziquone, TURBT, Stage Ta, G1-G2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2015 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Posted 27 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder cancer (NMIBC), ≤3.5 centimeters (cm) in diameter, all of which must had been fully resected at TURBT.
In addition to Screening, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.
Following TURBT on Day 1, eligible participants were randomized to one of three treatment arms in a 1:1:1 ratio.
Arm 1 : One dose of Apaziquone. Arm 2 : Two Doses of Apaziquone. Arm 3 : Placebo. Primary endpoint was to evaluate the Time to Recurrence with either a one instillation of 4 mg apaziquone or two instillations of 4 milligram (mg) apaziquone relative to placebo instillation following TURBT in a participant with NMIBC who received TURBT.
Detailed description
This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder tumors, ≤3.5 cm in diameter, all of which must have been fully resected at TURBT.
In addition to Screening, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.
Following TURBT on Day 1, eligible participants were randomized to one of three treatment arms in a 1:1:1 ratio :
Arm 1 : One Dose of Apaziquone:
- Day 1: administration of 4 mg of apaziquone 60±30 minutes post-TURBT
- Day 15 (±5 days): administration of placebo
Arm 2 : Two Doses of Apaziquone :
- Day 1: administration of 4 mg of apaziquone 60±30 minutes post-TURBT
- Day 15 (±5 days): administration of 4 mg of apaziquone
Arm 3: Placebo :
- Day 1 : administration of placebo 60±30 minutes post-TURBT
- Day 15 (±5 days) : administration of placebo
Once randomized, Day 1 study drug instillation occurred 60 ±30 minutes post TURBT. Participants returned on Day 15 (±5 days) for a second instillation unless their pathology results showed non Ta, G1-G2 histology; in the absence of local pathology results by the Day 15 visit, participants received a second instillation of study drug. All histology specimens were reviewed by a local pathology laboratory and all clinical treatment decisions and study analyses were based on the local pathology review. Participants whose pathology was other than Ta, G1-G2 were followed for safety at Day 35 (±5 days) from the last dose of study drug and then discontinued from the study.
Participants with pathology confirmed Ta, G1-G2 disease were followed according to the schedule below :
- Cystoscopic examination and urine cytology every 90 days (±10 days) (calculated from date of TURBT) through 24 months for tumor recurrence and progression.
- If at any time during the 24 months follow up period there was a tumor recurrence, the participant continued on study with follow-up cystoscopic examination and urine cytology every 90 days (±10 days) (calculated from date of TURBT) through the end of 24 months. Participants with a recurrence were permitted to have a follow-up TURBT.
- If at any time during the 24 months follow up period there was a tumor recurrence and/or participant started on another therapy, the participant was followed by telephone, for safety every 90 days (±10 days) (calculated from date of TURBT) through the end of 24 months.
Duration of Study: The duration of the study for each participant was approximately 24 months including:
- Screening Period : 30-days
- Treatment Period : Day 1 and Day 15 (±5 days)
- Safety and Follow-up Period: 24-months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Dose Apaziquone | Experimental | Drug: Apaziquone, Other: PlaceboParticipants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post transurethral resection of bladder tumor (TURBT) on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days). |
| 2 Dose Apaziquone | Experimental | Drug: ApaziquoneParticipants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of 4 mg of apaziquone by intravesical administration via an indwelling catheter on Day 15 (±5 days). |
| Placebo | Placebo comparator | Other: PlaceboParticipants were randomized to receive first dose of matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of matching placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- Participant had an active concurrent malignancy/life-threatening disease. If there was a history of prior malignancies/life-threatening diseases, the participant was to be disease-free for at least 5 years. Participant with other prior malignancies less than 5 years before study entry could have still been enrolled if they had received treatment resulting in complete resolution of the cancer and currently had no clinical, radiologic, or laboratory evidence of active or recurrent disease.
- Participant had positive urine cytology for malignancy at Screening.
- Participant had an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the participant to receive protocol treatment.
- Participant had used any investigational drugs, biologics, or devices within 30 days prior to study treatment or planned to use any of these during the course of the study.
- Participant had any prior intravesical chemotherapy, immunotherapy, or previous exposure to apaziquone.
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: EOquinOne dose of apaziquone administered by intravesical administration | Drug | 1 Dose Apaziquone, 2 Dose Apaziquone |
| PlaceboMatching placebo (containing 12 mg FD\&C red #40, 15 mg sodium chloride, and 10 mg mannitol was supplied in identical appearing vials) by intravesical administration. | Other | 1 Dose Apaziquone, Placebo |
Primary outcome
Time to Recurrence
Time frame: From randomization to the date of first histologically confirmed recurrence of bladder cancer (up to 1.5 years)
Time from randomization to the date of histologically confirmed recurrence of bladder cancer. A recurrence was defined as any pathologically confirmed disease of ≥Ta tumor histology or carcinoma in situ (CIS) post-treatment.
4 secondary outcomes
2-Year Recurrence Rate
Time frame: 2 years
1-Year Recurrence Rate
Time frame: 1 year
Time to Progression
Time frame: From randomization to the date of first disease progression (up to 1.5 years)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death
Time frame: Up to 1.5 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: 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 1 site in United States.
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 0 inclusion and 21 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 27 Oct 2021. 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 United States. 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 27 Sep 2021). 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: From randomization to the date of first histologically confirmed recurrence of bladder cancer (up to 1.5 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 27 Oct 2021.