Bladder CancerPhase 3NCT03224182
A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT)
A Phase 3 study testing Qapzola in people with Bladder Cancer, run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in participants with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC), assessed according to the 2016 American Urology Association (AUA) Guidelines. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Qapzola
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2017to 26 Sep 2019
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have had a clinical diagnosis of low- to intermediate-risk non-muscle invasive bladder cancer according to the 2016 American Urological Association (AUA) Guidelines, except for strongly-suspected papillary urothelial neoplasm of low malignant potential (PUNLMP).
- Participant was willing to give written informed consent and was able to adhere to dosing and visit schedules, and meet all study requirements.
- Participant was at least 18 years of age and <90 years of age at the time Informed Consent is signed.
- Participant was willing to practice two forms of contraception, one of which must have been a barrier method, from study entry until at least 35 days after study treatment. Participants surgically sterilized or who were postmenopausal for at least 1 year (defined as more than 12 months since last menses) did not require contraception.
- Females of childbearing potential had a negative pregnancy test within 30 days prior to randomization. Females who were postmenopausal for at least 1 year (defined as more than 12 months since last menses) or were surgically sterilized did not require this test.
Who cannot join
- Participant had malignancy or life-threatening systemic disease or a history of advanced, serious, life-threatening malignancy/disease within the last 5 years, except very low-risk prostate cancer.
- Participant had used any investigational drugs, biologics (vaccines, antibodies), or devices within 30 days prior to study treatment or had plans to use any of these during the course of the study.
- Participant had received any pelvic radiotherapy (including external beam and/or brachytherapy).
- Participant had a history of allergy to red color food dye or any other component of Qapzola, placebo, or their diluents.
- Participant had a surgical procedure 4 weeks prior to TURBT or had other surgical procedures performed at the time of TURBT or within 4 weeks after TURBT.
- Participant had any unstable or uncontrolled medical condition that would make it potentially unsafe to undergo TURBT including a previous stroke or myocardial infarction within 6 months.
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- 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 study treatment or undergo study procedures.
- Participant had a bleeding disorder or a screening platelet count <100×10^9/per liter (L), or required continuous anticoagulation or bridging anticoagulation during the procedure.
- Participant had a hemoglobin value <10 grams per deciliter (g/dL) at Screening.
- Participant had confirmed extravesical urothelial disease (upper tract and urethral including prostatic urethral).
- Participant had history of previous bladder cancer:
- High-Risk NMIBC as classified per the 2016 AUA Guidelines
- Bladder cancer that was muscle invasive or positive for lymph node or distant metastasis.
- Participant had received any previous intravesical therapy for bladder cancer- chemotherapy, immunotherapy, or previous exposure to Qapzola in the previous 3 years.
- Participant had a tumor in the bladder diverticulum.
- Participant had a history of interstitial cystitis.
- Participant was pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Two-Arm, Single-Dose, Double-Blind, Placebo-CONtrolled Phase 3 Study of Intravesical Qapzola™ (Apaziquone) as a Chemotherapy Adjuvant to TransUrEthral Resection of Bladder Tumors in Patients With Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer (CONQUER)
This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in participants with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC), assessed according to the 2016 American Urology Association (AUA) Guidelines. Specifically, only participants with the following low-to intermediate-risk tumor characteristics were included in the study.
2016 American Urological Association Stratification for Non-Muscle Invasive Bladder Cancer:
Read more
Low Risk
- Low grade solitary Ta ≤3 centimeters (cm)
- Papillary urothelial neoplasm of low malignant potential (PUNLMP)
Intermediate Risk
- Recurrence within 1 year, low-grade Ta
- Solitary low-grade Ta >3 cm
- Low-grade Ta, multifocal
- High-grade Ta, ≤3 cm (solitary tumor)
Read the detailed description
In addition to other Screening assessments, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor of Ta histology, including PUNLMP, although participants with strongly suspected PUNLMP at Screening or transurethral resection of bladder tumor (TURBT) were not to be enrolled in the study. The qualifying cystoscopy could be performed up to 45 days prior to signing the informed consent.
Eligible participants were randomized in a 2:1 ratio to either:
- Arm 1: One dose of 8 milligrams (mg) Qapzola
- Arm 2: One dose of placebo
Once approved for randomization, participants underwent TURBT on Day 1 and the study drug instillation occurred at 60 ± 30 minutes post-TURBT and was retained for 60 minutes (±5 minutes) in the bladder. All histology specimens were reviewed by a local pathology laboratory and all clinical treatment decisions were based on the local pathology review. Participant target disease was confirmed and efficacy analyses were performed based on the pathology results. The target study population was low- to intermediate-risk participants who had Ta histology, including PUNLMP, as confirmed by a pathology laboratory. Participants with strongly suspected PUNLMP at Screening or TURBT were not to be enrolled in the study. Participants whose tumor histology did not meet the criteria for eligibility, as confirmed by pathology (Non-Target Population), were to be followed up for safety on Day 35 (±5 days) (Safety Follow-up Visit) and were discontinued from the study. If the pathology results were delayed beyond 35 days, the Safety Follow-up Visit was to be conducted when the results were available for these participants.
Participants who had pathology-confirmed target histology did not receive additional medications to treat NMIBC during the follow-up while on the study. All target disease participants were to be followed until either a confirmed tumor recurrence, additional bladder cancer treatments, or until the End-of-Study, whichever occurred first.
The primary analysis was conducted once the required number of recurrence events were observed. A recurrence was defined as any pathologically confirmed disease of ≥Ta histology or carcinoma in situ (CIS) post-treatment. The number of events needed to perform the final primary endpoint analysis was estimated based on the recurrence rate at 24 months from previous studies. The follow-up schedule is below:
- Cystoscopic examination (all participants) and urine cytology (only participants with a Baseline diagnosis of intermediate-risk NMIBC) every 3 months (±30 days) (calculated from date of TURBT) for 2 years for tumor recurrence and progression and then every 6 months (±60 days) until either a confirmed tumor recurrence or the End-of-Study, whichever occurred first.
- If at any time during the study there was a histologically confirmed tumor recurrence, the participants discontinued from the study at that time and could then be treated per the Investigator's standard of care.
The study was to end (End-of-Study) when the required number of events for the primary endpoint analysis was accrued.
Duration of Study: The duration of the study for each participant was as follows:
- Screening Period: up to 30 days
- Treatment: Day 1
- Safety Follow-up: Day 35 (±5 days) after treatment
- Follow-up Period: No follow-up in non-Target Population. Until either a confirmed tumor recurrence or the End-of-Study, whichever occurred first in the Target Population.
- Conditions
- Bladder Cancer
- Being tested
- Qapzola, Placebo
- 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.
QapzolaDrug
Qapzola administered by the intravesical route.
PlaceboDrug
Qapzole-matching placebo administered by the intravesical route.
| Study group | Role | What they receive |
|---|---|---|
| Qapzola | Experimental | Participants were randomized to receive a single dose of Qapzola 8 mg 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 and retained in the bladder for 60 ± 5 minutes. Receives: Drug: Qapzola |
| Placebo | Placebo comparator | Participants were randomized to receive a single dose of Qapzole-matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes. 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 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 date of histologically confirmed recurrence of bladder cancer (up to 2.1 years)
Secondary outcomes (3)
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
Time to Disease 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 first disease progression (up to 2.1 years)
Number of Participants With Treatment-emergent Adverse Event (TEAE), Treatment-related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, TEAEs of Special Interest, and Death
An AE was untoward medical occurrence in a participant who had study drug without possibility of causal relationship. TEAEs: AEs that occurred from dose of treatment until 35 days after study drug administration. Treatment-related AEs included TEAEs with relationship to study treatment (possible, probable, definite/missing). SAE was AE resulting in: death; initial/prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly. TEAEs of special interest were AEs of grade ≥3 dysuria and hematuria per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade ≥3 hematuria included gross hematuria; transfusion, hospitalization indicated; elective endoscopy, radiologic or operative intervention indicated; limiting self-care activities of daily living (ADL), life-threatening events/death. Grade ≥3 dysuria included severe pain; pain/analgesics severely interfering with ADL and disabling.
Measured: Up to 2.1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start4 Aug 2017
- Primary completion26 Sep 2019
- Study completion26 Sep 2019
Why it stopped: Suspended development
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
- Model description
- This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in participants with low- to intermediate-risk NMIBC.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shanta Chawla, MD, Study director, Spectrum Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224182
- Sponsor's protocol ID
- SPI-QAP-306
- Status last verified
- Aug 2021
- First submitted
- 14 Apr 2017
- Last updated
- 28 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Two-Arm, Single-Dose, Double-Blind, Placebo-CONtrolled Phase 3 Study of Intravesical Qapzola™ (Apaziquone) as a Chemotherapy Adjuvant to TransUrEthral Resection of Bladder Tumors in Patients With Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer (CONQUER)
- ClinicalTrials.gov ID
- NCT03224182
- Acronym / sponsor ID
- SPI-QAP-306
- Conditions
- Bladder Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended development
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 28 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 randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in participants with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC), assessed according to the 2016 American Urology Association (AUA) Guidelines. Specifically, only participants with the following low-to intermediate-risk tumor characteristics were included in the study.
2016 American Urological Association Stratification for Non-Muscle Invasive Bladder Cancer:
Low Risk
- Low grade solitary Ta ≤3 centimeters (cm)
- Papillary urothelial neoplasm of low malignant potential (PUNLMP)
Intermediate Risk
- Recurrence within 1 year, low-grade Ta
- Solitary low-grade Ta >3 cm
- Low-grade Ta, multifocal
- High-grade Ta, ≤3 cm (solitary tumor)
Detailed description
In addition to other Screening assessments, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor of Ta histology, including PUNLMP, although participants with strongly suspected PUNLMP at Screening or transurethral resection of bladder tumor (TURBT) were not to be enrolled in the study. The qualifying cystoscopy could be performed up to 45 days prior to signing the informed consent.
Eligible participants were randomized in a 2:1 ratio to either:
- Arm 1: One dose of 8 milligrams (mg) Qapzola
- Arm 2: One dose of placebo
Once approved for randomization, participants underwent TURBT on Day 1 and the study drug instillation occurred at 60 ± 30 minutes post-TURBT and was retained for 60 minutes (±5 minutes) in the bladder. All histology specimens were reviewed by a local pathology laboratory and all clinical treatment decisions were based on the local pathology review. Participant target disease was confirmed and efficacy analyses were performed based on the pathology results. The target study population was low- to intermediate-risk participants who had Ta histology, including PUNLMP, as confirmed by a pathology laboratory. Participants with strongly suspected PUNLMP at Screening or TURBT were not to be enrolled in the study. Participants whose tumor histology did not meet the criteria for eligibility, as confirmed by pathology (Non-Target Population), were to be followed up for safety on Day 35 (±5 days) (Safety Follow-up Visit) and were discontinued from the study. If the pathology results were delayed beyond 35 days, the Safety Follow-up Visit was to be conducted when the results were available for these participants.
Participants who had pathology-confirmed target histology did not receive additional medications to treat NMIBC during the follow-up while on the study. All target disease participants were to be followed until either a confirmed tumor recurrence, additional bladder cancer treatments, or until the End-of-Study, whichever occurred first.
The primary analysis was conducted once the required number of recurrence events were observed. A recurrence was defined as any pathologically confirmed disease of ≥Ta histology or carcinoma in situ (CIS) post-treatment. The number of events needed to perform the final primary endpoint analysis was estimated based on the recurrence rate at 24 months from previous studies. The follow-up schedule is below:
- Cystoscopic examination (all participants) and urine cytology (only participants with a Baseline diagnosis of intermediate-risk NMIBC) every 3 months (±30 days) (calculated from date of TURBT) for 2 years for tumor recurrence and progression and then every 6 months (±60 days) until either a confirmed tumor recurrence or the End-of-Study, whichever occurred first.
- If at any time during the study there was a histologically confirmed tumor recurrence, the participants discontinued from the study at that time and could then be treated per the Investigator's standard of care.
The study was to end (End-of-Study) when the required number of events for the primary endpoint analysis was accrued.
Duration of Study: The duration of the study for each participant was as follows:
- Screening Period: up to 30 days
- Treatment: Day 1
- Safety Follow-up: Day 35 (±5 days) after treatment
- Follow-up Period: No follow-up in non-Target Population. Until either a confirmed tumor recurrence or the End-of-Study, whichever occurred first in the Target Population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in participants with low- to intermediate-risk NMIBC.
| Arm | Type | Receives |
|---|---|---|
| Qapzola | Experimental | Drug: QapzolaParticipants were randomized to receive a single dose of Qapzola 8 mg 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 and retained in the bladder for 60 ± 5 minutes. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants were randomized to receive a single dose of Qapzole-matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must have had a clinical diagnosis of low- to intermediate-risk non-muscle invasive bladder cancer according to the 2016 American Urological Association (AUA) Guidelines, except for strongly-suspected papillary urothelial neoplasm of low malignant potential (PUNLMP).
- Participant was willing to give written informed consent and was able to adhere to dosing and visit schedules, and meet all study requirements.
- Participant was at least 18 years of age and <90 years of age at the time Informed Consent is signed.
- Participant was willing to practice two forms of contraception, one of which must have been a barrier method, from study entry until at least 35 days after study treatment. Participants surgically sterilized or who were postmenopausal for at least 1 year (defined as more than 12 months since last menses) did not require contraception.
- Females of childbearing potential had a negative pregnancy test within 30 days prior to randomization. Females who were postmenopausal for at least 1 year (defined as more than 12 months since last menses) or were surgically sterilized did not require this test.
Key exclusion criteria (17 listed)
- Participant had malignancy or life-threatening systemic disease or a history of advanced, serious, life-threatening malignancy/disease within the last 5 years, except very low-risk prostate cancer.
- Participant had used any investigational drugs, biologics (vaccines, antibodies), or devices within 30 days prior to study treatment or had plans to use any of these during the course of the study.
- Participant had received any pelvic radiotherapy (including external beam and/or brachytherapy).
- Participant had a history of allergy to red color food dye or any other component of Qapzola, placebo, or their diluents.
- Participant had a surgical procedure 4 weeks prior to TURBT or had other surgical procedures performed at the time of TURBT or within 4 weeks after TURBT.
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 |
|---|---|---|
| QapzolaQapzola administered by the intravesical route. | Drug | Qapzola |
| PlaceboQapzole-matching placebo administered by the intravesical route. | Drug | Placebo |
Primary outcome
Time to Recurrence
Time frame: From randomization to date of histologically confirmed recurrence of bladder cancer (up to 2.1 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.
3 secondary outcomes
2-Year Recurrence Rate
Time frame: 2 years
Time to Disease Progression
Time frame: From randomization to first disease progression (up to 2.1 years)
Number of Participants With Treatment-emergent Adverse Event (TEAE), Treatment-related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, TEAEs of Special Interest, and Death
Time frame: Up to 2.1 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Shanta Chawla, MD study director
Spectrum Pharmaceuticals, Inc
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 Qapzola 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 5 inclusion and 17 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 28 Sep 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 28 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 date of histologically confirmed recurrence of bladder cancer (up to 2.1 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 28 Sep 2021.