Trial Outcomes & Findings for A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT) (NCT NCT03224182)

Last Updated: 2021-09-28

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

118 participants

Primary outcome timeframe

From randomization to date of histologically confirmed recurrence of bladder cancer (up to 2.1 years)

Results posted on

2021-09-28

Participant Flow

Participants with low-to intermediate-risk non-muscle invasive bladder cancer (NMIBC) were enrolled at 34 investigative sites in the United States (US) from 04 August 2017 to 26 September 2019.

A total of 118 participants were randomized into the study, out of which 1 participant completed the study.

Participant milestones

Participant milestones
Measure	Qapzola 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.	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.
Overall Study STARTED	81	37
Overall Study Safety Population	73	36
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	81	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Qapzola 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.	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.
Overall Study Study Drug Not Instilled	6	1
Overall Study Histology Other than Low- to Intermediate-Risk NMIBC	22	11
Overall Study Withdrew of Consent	4	2
Overall Study Investigator Decision	3	1
Overall Study Sponsor Decision	26	12
Overall Study Participant Refused Follow-up Procedures/Cystoscopy	4	0
Overall Study Lost to Follow-up	1	0
Overall Study Participant Had Recurrence	11	5
Overall Study Death	0	1
Overall Study Reason not Specified	3	3
Overall Study Other	1	0

Baseline Characteristics

A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Qapzola n=73 Participants Participants were randomized to receive a single dose of Qapzola 8 mg 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.	Placebo n=36 Participants 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.	Total n=109 Participants Total of all reporting groups
Age, Continuous	66.2 years STANDARD_DEVIATION 10.28 • n=5 Participants	68.9 years STANDARD_DEVIATION 10.16 • n=7 Participants	67.1 years STANDARD_DEVIATION 10.28 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	23 Participants n=7 Participants	81 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	71 Participants n=5 Participants	31 Participants n=7 Participants	102 Participants n=5 Participants
Race/Ethnicity, Customized Race · Race-Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	58 Participants n=5 Participants	29 Participants n=7 Participants	87 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to date of histologically confirmed recurrence of bladder cancer (up to 2.1 years)

Population: Data for this outcome measure was not collected due to early termination of study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Data for this outcome measure was not collected due to early termination of study.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization to first disease progression (up to 2.1 years)

Population: Data for this outcome measure was not collected due to early termination of study.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2.1 years

Population: Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.

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.

Outcome measures

Outcome measures
Measure	Qapzola n=73 Participants Participants were randomized to receive a single dose of Qapzola 8 mg 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.	Placebo n=36 Participants 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.
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 TEAEs	23 Participants	7 Participants
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 Treatment-related AEs	8 Participants	4 Participants
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 SAEs	1 Participants	2 Participants
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 TEAEs Leading to Discontinuation	0 Participants	0 Participants
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 TEAE of Special Interest: Dysuria	0 Participants	0 Participants
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 TEAE of Special Interest: Haematuria	0 Participants	1 Participants
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 Death	0 Participants	1 Participants

Adverse Events

Qapzola

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Qapzola n=73 participants at risk Participants were randomized to receive a single dose of Qapzola 8 mg 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.	Placebo n=36 participants at risk 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.
Renal and urinary disorders Haematuria	0.00% 0/73 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.	2.8% 1/36 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.
Renal and urinary disorders Bladder spasm	1.4% 1/73 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.	0.00% 0/36 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.
Cardiac disorders Cardiac Arrest	0.00% 0/73 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.	2.8% 1/36 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.

Other adverse events

Other adverse events
Measure	Qapzola n=73 participants at risk Participants were randomized to receive a single dose of Qapzola 8 mg 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.	Placebo n=36 participants at risk 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.
Infections and infestations Urinary tract infection	6.8% 5/73 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.	8.3% 3/36 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.
Renal and urinary disorders Bladder spasm	11.0% 8/73 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.	5.6% 2/36 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.
Renal and urinary disorders Dysuria	5.5% 4/73 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.	0.00% 0/36 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.
Renal and urinary disorders Haematuria	8.2% 6/73 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.	2.8% 1/36 • Up to 2.1 years Safety Population included all treated participants, classified according to the actual treatment received, regardless of random assignment.

Additional Information

Shanta Chawla

Spectrum Pharmaceuticals, Inc, Research and Development Office 157 Technology Drive Irvine, CA 92618

Phone: (949) 788-6700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place