Trial Outcomes & Findings for Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer (NCT NCT01410565)

Last Updated: 2016-12-13

Results Overview

Time to recurrence is the time from randomization to the date of first histologically confirmed recurrence of bladder cancer (for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

66 participants

Primary outcome timeframe

Recurrence of cancer in the bladder during 24 months of follow-up

Results posted on

2016-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Apaziquone Apaziquone: Apaziquone 4 mg in 40 mL diluent Apaziquone: Apaziquone in the Double Blind Phase	Placebo Placebo Placebo: Placebo in the Double Blind Phase	Open Label-Apaziquone
Open Label Phase Apaziquone STARTED	0	0	66
Open Label Phase Apaziquone COMPLETED	0	0	58
Open Label Phase Apaziquone NOT COMPLETED	0	0	8
Double Blind Phase STARTED	13	15	0
Double Blind Phase COMPLETED	0	0	0
Double Blind Phase NOT COMPLETED	13	15	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apaziquone n=13 Participants Apaziquone 4 mg in 40 mL diluent Apaziquone in the Double Blind Phase	Placebo n=15 Participants Placebo Placebo in the Double Blind Phase	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	65.5 years STANDARD_DEVIATION 11.77 • n=5 Participants	70.5 years STANDARD_DEVIATION 12.66 • n=7 Participants	68.2 years STANDARD_DEVIATION 12.30 • n=5 Participants
Gender Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Gender Male	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Recurrence of cancer in the bladder during 24 months of follow-up

Population: All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase. Participants without recurrence were censored.

Outcome measures

Outcome measures
Measure	Apaziquone n=13 Participants Apaziquone: Apaziquone 4 mg in 40 mL diluent Apaziquone in the Double Blind Phase	Placebo n=15 Participants Placebo Placebo in the Double Blind Phase
Time to Recurrence	9.2 months Interval 9.2 to 9.2	7.3 months Interval 2.3 to 8.5

SECONDARY outcome

Timeframe: 24 months

Population: All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase.

Measurement the number of participants with the recurrence at 24 months.

Outcome measures

Outcome measures
Measure	Apaziquone n=13 Participants Apaziquone: Apaziquone 4 mg in 40 mL diluent Apaziquone in the Double Blind Phase	Placebo n=15 Participants Placebo Placebo in the Double Blind Phase
Recurrence Rate at 24 Months	1 participants	4 participants

SECONDARY outcome

Timeframe: 24 Months from Randomization

Population: All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase.

TEAEs will be mainly characterized by the number of treatment emergent adverse events and treatment related AEs that occur or worsen after the first dose of study treatment.

Outcome measures

Outcome measures
Measure	Apaziquone n=13 Participants Apaziquone: Apaziquone 4 mg in 40 mL diluent Apaziquone in the Double Blind Phase	Placebo n=15 Participants Placebo Placebo in the Double Blind Phase
Participants With Treatment Emergent Adverse Events (TEAEs)	11 participants	12 participants

Adverse Events

Apaziquone

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Apaziquone n=13 participants at risk Apaziquone: Apaziquone 4 mg in 40 mL diluent Apaziquone: Apaziquone in the Double Blind Phase	Placebo n=15 participants at risk Placebo Placebo: Placebo in the Double Blind Phase
Cardiac disorders Arterio Sclerosis	7.7% 1/13 • Number of events 1	0.00% 0/15
Renal and urinary disorders Prostate Cancer	0.00% 0/13	6.7% 1/15 • Number of events 1

Other adverse events

Other adverse events
Measure	Apaziquone n=13 participants at risk Apaziquone: Apaziquone 4 mg in 40 mL diluent Apaziquone: Apaziquone in the Double Blind Phase	Placebo n=15 participants at risk Placebo Placebo: Placebo in the Double Blind Phase
Renal and urinary disorders Dysuria	38.5% 5/13 • Number of events 5	13.3% 2/15 • Number of events 2
Renal and urinary disorders Pollakiuria	30.8% 4/13 • Number of events 4	6.7% 1/15 • Number of events 1
Renal and urinary disorders Bladder pain	15.4% 2/13 • Number of events 2	0.00% 0/15
Renal and urinary disorders Hematuria	0.00% 0/13	26.7% 4/15 • Number of events 4
Gastrointestinal disorders Constipation	15.4% 2/13 • Number of events 2	26.7% 4/15 • Number of events 4
Renal and urinary disorders Urinary retention	15.4% 2/13 • Number of events 2	13.3% 2/15 • Number of events 2

Additional Information

Gajanan Bhat

Spectrum Pharmaceutical Inc.

Phone: 949-743-9219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place