Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Urinary Bladder Neoplasms

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Urogenital Neoplasms

Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

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Apaziquone

TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT

TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT

A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT

A single intravesical dose of placebo instilled into the bladder post-TURBT

Placebo

TransUrethral Resection of the Bladder Tumor

TURBT

Shanta Chawla, MD

The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. Within 14 days of Screening, eligible patients underwent a TURBT during Visit 1 (Day 0) following which they were immediately randomized in a 1:1 ratio to receive either placebo or 4 mg apaziquone, instilled in a volume of 40 mL into the bladder within 6 hours from the end of the TURBT procedure. After a 60-minute retention period, study drug was drained from the bladder.

A postoperative follow-up examination and review of the local pathology report were performed at Visit 2, which occurred 21 days (±10 days) after the TURBT (Week 3).

* If the histology of the patient's tumor was confirmed as Ta, G1-G2 (ie, low grade according to World Health Organization \[WHO\]/International Society of Urologic Pathology \[ISUP\] classification), no further treatment was given and the patient was observed cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).
* If the histology of the patient's tumor was other than Ta, G1 or G2 (low grade \[WHO/ISUP classification\]), further treatment was given in accordance with current treatment guidelines, and the patient was followed up cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).

All patients were to be followed for 2 years.

Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single-Dose Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer (Protocol SPI-612)

The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.

The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.

The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.

The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.

The number of histologically confirmed recurrences during the course of the study.

The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause

The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause

The number of months from randomization to death from any cause.

Spectrum Pharmaceuticals, Inc

Apaziquone: TURBT + a single intravesical dose of EOquin® 4mg in 40ml instilled into the bladder post-TURBT

Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT

Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT

Total

Age, Continuous

65-75

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Canada

United States

Poland

Region of Enrollment

Gajanan Bhat, PhD

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.

Recurrence Rate at 2 Years

Time to Recurrence

Progression Rate at 2 Years

Time to Progression

Number of Recurrences Per Patient

Disease-Free Interval

Disease-Free Survival

Overall Survival

Overall Study

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

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single Dose Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer (Protocol SPI-611)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)	NCT00598806	Bladder Cancer	Apaziquone Placebo TURBT	18 Years -	Spectrum Pharmaceuticals, Inc
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)	NCT00598806	Bladder Cancer	Apaziquone Placebo TURBT	18 Years -	Spectrum Pharmaceuticals, Inc
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)	NCT00461591	Bladder Cancer	Apaziquone Placebo TURBT	18 Years -	Spectrum Pharmaceuticals, Inc

Spots Global Cancer Trial Database for noninvasive bladder cancer