A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Tr… (NCT03224182) | Clinical Trial Compass
TerminatedPhase 3
A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT)
Stopped: Suspended development
United States118 participantsStarted 2017-08-04
Plain-language 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. 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)
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to Recurrence
Timeframe: From randomization to date of histologically confirmed recurrence of bladder cancer (up to 2.1 years)
. 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.
. 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.