Trial · NCT00461591

Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)

NCT00461591, Phase 3, Completed, Spectrum Pharmaceuticals, Inc; results first posted 2017-08-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611). Trials, record NCT00461591. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00461591

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
NCT number: NCT00461591
Status: Completed
Phases: Phase 3
Enrollment: 802 participants, actual
Lead sponsor: Spectrum Pharmaceuticals, Inc
Conditions: Bladder Cancer
Interventions: Apaziquone, Placebo, TURBT
First posted: 2007-04-18
Last updated: 2021-03-30
Results first posted: 2017-08-15

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Recurrence Rate at 2 Years	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.
Secondary	Time to Recurrence	2 years	The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.
Secondary	Progression Rate at 2 Years	2 years	The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.
Secondary	Time to Progression	2 years	The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.
Secondary	Number of Recurrences Per Patient	2 years	The number of histologically confirmed recurrences during the course of the study.
Secondary	Disease Free Interval	2 years	The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause
Secondary	Disease Free Survival	2 years	The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause
Secondary	Overall Survival	2 years	The number of months from randomization to death from any cause.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Recurrence Rate at 2 Years	2 years	Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Recurrence	2 years	Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.	months	MEAN
SECONDARY	Progression Rate at 2 Years	2 years	Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Progression	2 years	Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.	months	MEAN
SECONDARY	Number of Recurrences Per Patient	2 years	Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.	times	MEAN
SECONDARY	Disease Free Interval	2 years	Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.	months	MEAN
SECONDARY	Disease Free Survival	2 years	Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.	months	MEAN
SECONDARY	Overall Survival	2 years	Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.	months	MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Recurrence Rate at 2 Years	Apaziquone	Recurrence	112		Participants
Recurrence Rate at 2 Years	Placebo	Recurrence	121		Participants
Recurrence Rate at 2 Years	Apaziquone	Non-Recurrence	183		Participants
Recurrence Rate at 2 Years	Placebo	Non-Recurrence	150		Participants
Time to Recurrence	Apaziquone		18.3	Standard Error 0.47	months
Time to Recurrence	Placebo		16.7	Standard Error 0.55	months
Progression Rate at 2 Years	Apaziquone	Progression	30		Participants
Progression Rate at 2 Years	Placebo	Progression	39		Participants
Progression Rate at 2 Years	Apaziquone	Non-Progression	265		Participants
Progression Rate at 2 Years	Placebo	Non-Progression	232		Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Apaziquone	406
Overall Study	STARTED	Placebo	396
Overall Study	COMPLETED	Apaziquone	317
Overall Study	COMPLETED	Placebo	311
Overall Study	NOT COMPLETED	Apaziquone	89
Overall Study	NOT COMPLETED	Placebo	85

Source ClinicalTrials.gov

Adverse events384

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Urinary tract infection	Infections and infestations	Apaziquone	70	406
other	Urinary tract infection	Infections and infestations	Placebo	58	396
other	Procedural pain	Injury, poisoning and procedural complications	Apaziquone	31	406
other	Procedural pain	Injury, poisoning and procedural complications	Placebo	27	396
other	Bladder pain	Renal and urinary disorders	Apaziquone	22	406
other	Bladder pain	Renal and urinary disorders	Placebo	18	396
other	Bladder spasm	Renal and urinary disorders	Apaziquone	29	406
other	Bladder spasm	Renal and urinary disorders	Placebo	23	396
other	Dysuria	Renal and urinary disorders	Apaziquone	74	406
other	Dysuria	Renal and urinary disorders	Placebo	67	396

1 to 10 of 384Source ClinicalTrials.gov

See all 384 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Apaziquone	11	406
Total, all-cause mortality	Placebo	13	396
Total, other adverse events	Apaziquone	312	406
Total, other adverse events	Placebo	285	396
Total, serious adverse events	Apaziquone	93	406
Total, serious adverse events	Placebo	98	396

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Apaziquone vs Placebo: deaths from any cause	Trial comparisons
Apaziquone vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00461591

GET https://conductscience.org/api/trials/v1/NCT00461591/events?page=2

API reference For AI assistants