A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Patients Undergoing TURBT
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|ClinicalTrials.gov Identifier: NCT03224182|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : August 10, 2017
This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in patients with low- to intermediate-risk NMIBC, assessed according to the 2016 American Urology Association (AUA) Guidelines. Specifically, only patients with the following low-to intermediate risk tumor characteristics will be included in the study.
2016 American Urological Association Stratification for Non-Muscle Invasive Bladder Cancer:
- Low grade solitary Ta ≤3cm: a
- PUNLMP: a, b
- Recurrence within 1 year, low-grade Ta: a
- Solitary low-grade Ta >3 cm: a
- Low-grade Ta, multifocal: a
- High-grade Ta, ≤3 cm (solitary tumor): a
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Qapzola Drug: Placebo||Phase 3|
In addition to other Screening assessments, patients will undergo an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor of Ta histology, including PUNLMP, although patients with strongly suspected PUNLMP at Screening or TURBT should not be enrolled in the study. The qualifying cystoscopy may be performed up to 45 days prior to signing the informed consent.
Eligible patients will be randomized in a 2:1 ratio to either:
- Arm 1: One dose of 8 mg Qapzola
- Arm 2: One dose of placebo
Once approved for randomization, patients will undergo TURBT on Day 1 and the study drug instillation will occur at 60 ± 30 minutes post-TURBT and will be retained for 60 minutes (±5 minutes) in the bladder. All histology specimens will be reviewed by a local pathology laboratory and all clinical treatment decisions will be based on the local pathology review. Patient target disease will be confirmed and efficacy analyses will be performed based on the pathology results. The target study population is low- to intermediate-risk patients who have Ta histology, including PUNLMP, as confirmed by a pathology laboratory. Patients with strongly suspected PUNLMP at Screening or TURBT should not be enrolled in the study. Patients whose tumor histology does not meet the criteria for eligibility, as confirmed by pathology (Non-Target Population), will be followed up for safety on Day 35 (±5 days) (Safety Follow-up Visit) and will be discontinued from the study. If the pathology results are delayed beyond 35 days, the Safety Follow-up Visit will be conducted when the results are available for these patients.
Patients who have pathology confirmed target histology will not receive additional medications to treat NMIBC during the follow-up while on study. All target disease patients will be followed until either a confirmed tumor recurrence, additional bladder cancer treatments, or until the End-of-Study, whichever occurs first.
The primary analysis will be conducted once the required number of recurrence events are observed. A recurrence is defined as any pathologically confirmed disease of ≥Ta histology or 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 patients) and urine cytology (only patients 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 occurs first.
- If at any time during the study there is a histologically confirmed tumor recurrence, the patient will be discontinued from the study at that time and may then be treated per the Investigator's standard of care.
The study will end (End-of-Study) when the required number of events for the primary endpoint analysis are accrued.
Duration of Study: The duration of the study for each patient will be as follows:
- Screening Period: up to 30-days
- Treatment: Day 1
- Safety Follow-up: Day 35 (±5 days) (non-Target Population) or Month 3 Follow-up Visit (Target Population)
- Follow-up Period: No follow-up in non-Target Population. Until either a confirmed tumor recurrence or the End-of-Study, whichever occurs first in the Target Population.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in patients with low- to intermediate-risk NMIBC.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Single-Dose, Double-Blind, Placebo-CONtrolled Phase 3 Study of Qapzola™ (Apaziquone) as a Chemotherapy Adjuvant to TransUrEthral Resection of Bladder Tumors in Patients With Low- To-Intermediate-Risk NMIBC (CONQUER)|
|Actual Study Start Date :||June 28, 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||December 2022|
One dose of 8mg Qapzola on Day 1
One dose of 8 mg Qapzola on Day 1
Placebo Comparator: Placebo
One dose of placebo on Day 1
One dose of Placebo on Day 1
- Time to Recurrence [ Time Frame: Up-to 5 years ]To evaluate the Time to Recurrence in patients with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC) who receive either 8 mg Qapzola or placebo post transurethral resection of bladder tumor (TURBT).
- 2-Year Recurrence Rate [ Time Frame: 2- years for each patient ]proportion of patients who have a confirmed recurrence before or at the 2-year follow up period for each treatment arm.
- Time to Disease Progression [ Time Frame: up to 60 months ]Patients will be followed every 3 months for two years then every 6 months up to 60 months with surveillance cystoscopy and will complete the trial at documented recurrence regardless of progression. Progression is defined in the protocol as invasion into detrusor muscle >T2 disease. As these low and intermediate risk NMIBC groups are at high risk of recurrence and low risk of progression this is only secondary outcome.
- Safety - rate of treatment-related adverse events [ Time Frame: Up to 5 years ]Safety will be assessed by reported/elicited adverse events (AEs) that are related to the study drug regardless of treatment group.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224182
|Contact: Nawazish Khan, MDemail@example.com|
|United States, Pennsylvania|
|Urology Health Specialists, LLC||Recruiting|
|Bryn Mawr, Pennsylvania, United States, 19010|
|Contact: Guy Bernstein, MD|