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

• ClinicalTrials.gov Identifier: NCT00461591
• Recruitment Status: Completed
• First Posted: April 18, 2007
• Results First Posted: August 15, 2017
• Last Update Posted: March 30, 2021
• Sponsor: Spectrum Pharmaceuticals, Inc
• Information provided by (Responsible Party): Spectrum Pharmaceuticals, Inc

Tracking Information

• First Submitted Date: April 16, 2007
• First Posted Date: April 18, 2007
• Results First Submitted Date: July 14, 2017
• Results First Posted Date: August 15, 2017
• Last Update Posted Date: March 30, 2021
• Actual Study Start Date: April 2007
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 7, 2017)

Recurrence Rate at 2 Years [ 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.

• Original Primary Outcome Measures (submitted: April 17, 2007): Recurrence Rate at 2 years

Current Secondary Outcome Measures (submitted: September 7, 2017)

• Time to Recurrence [ Time Frame: 2 years ]
  The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.
• Progression Rate at 2 Years [ Time Frame: 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.
• Time to Progression [ Time Frame: 2 years ]
  The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.
• Number of Recurrences Per Patient [ Time Frame: 2 years ]
  The number of histologically confirmed recurrences during the course of the study.
• Disease Free Interval [ Time Frame: 2 years ]
  The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause
• Disease Free Survival [ Time Frame: 2 years ]
  The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause
• Overall Survival [ Time Frame: 2 years ]
  The number of months from randomization to death from any cause.

Original Secondary Outcome Measures (submitted: April 17, 2007)

• Time to Recurrence
• Progression to Higher Stage or Grade
• Number of Recurrences per Patient
• Disease Free Interval
• Disease Free Survival
• Overall Survival

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
• Official Title: 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)
• Brief Summary: 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Bladder Cancer

Intervention

• Drug: Apaziquone
  A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
  Other Name: EOquin®, Qapzola
• Drug: Placebo
  A single intravesical dose of placebo instilled into the bladder post-TURBT
• Procedure: TURBT
  TransUrethral Resection of the Bladder Tumor

Study Arms

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

  • Drug: Apaziquone
  • Procedure: TURBT
• Placebo Comparator: Placebo
  TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
  Interventions:

  • Drug: Placebo
  • Procedure: TURBT

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 5, 2012): 802
• Original Enrollment (submitted: April 17, 2007): 674
• Actual Study Completion Date: January 2012
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria: (All questions must be answered YES)

• Has the patient given written informed consent?
• Is the patient at least 18 years old?
• Does the patient have transitional cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2?
• If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
• If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days?
• Is the patient willing and able to abide by the protocol?

Exclusion Criteria: (All questions must be answered NO)

• Does the patient have more than 4 bladder tumors?
• Does any single bladder tumor exceed 3.5 cm in diameter?
• Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor <0.5 cm?
• Has the patient ever received Apaziquone?
• Does the patient have, or has the patient ever had, any bladder tumor known to be other than stage Ta or grade G1 or G2 (low grade [WHO/ISUP classification])?
• Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma?
• Does the patient have, or has the patient ever had, carcinoma in situ (CIS)?
• Does the patient have an active urinary tract infection?
• Does the patient have a bleeding disorder or a screening platelet count < 100 x 10^9/L?
• Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TURBT under general or spinal anesthesia?
• Does the patient have a screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 10^9/L or a screening creatinine > 2 mg/dL?
• Does the patient have a known immunodeficiency disorder?
• Has the patient received any investigational treatment within the past 30 days?
• Is the patient breast feeding?
• Does the patient have a history of interstitial cystitis?
• Does the patient have a history of allergy to red color food dye?
• Has the patient had transitional cell carcinoma of the bladder within the past 4 months?

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00461591
• Other Study ID Numbers: SPI-611
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Spectrum Pharmaceuticals, Inc
• Original Responsible Party: Not Provided
• Current Study Sponsor: Spectrum Pharmaceuticals, Inc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Shanta Chawla, MD; Spectrum Pharmaceuticals, Inc

• PRS Account: Spectrum Pharmaceuticals, Inc
• Verification Date: March 2021