A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT)
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|ClinicalTrials.gov Identifier: NCT03224182|
Recruitment Status : Terminated (Suspended development)
First Posted : July 21, 2017
Results First Posted : September 28, 2021
Last Update Posted : September 28, 2021
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 grade solitary Ta ≤3 centimeters (cm)
- Papillary urothelial neoplasm of low malignant potential (PUNLMP)
- Recurrence within 1 year, low-grade Ta
- Solitary low-grade Ta >3 cm
- Low-grade Ta, multifocal
- High-grade Ta, ≤3 cm (solitary tumor)
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Qapzola Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Care Provider, Investigator)|
|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)|
|Actual Study Start Date :||August 4, 2017|
|Actual Primary Completion Date :||September 26, 2019|
|Actual Study Completion Date :||September 26, 2019|
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.
Qapzola administered by the intravesical route.
Placebo Comparator: Placebo
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.
Qapzole-matching placebo administered by the intravesical route.
- 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.
- 2-Year Recurrence Rate [ Time Frame: 2 years ]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.
- Time to Disease Progression [ Time Frame: From randomization to first disease progression (up to 2.1 years) ]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.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224182
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53705|
|Study Director:||Shanta Chawla, MD||Spectrum Pharmaceuticals, Inc|