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

NCT00598806 | Completed Phase 3 Results

• 1 other identifier: SPI-612
• Study Type: interventional
• Target: 812
• Locations: 3 countries
• Sites: 77

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.

Conditions

Bladder Cancer

Keywords

Noninvasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence Rate at 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.

  2 years

Secondary Outcomes (7)

• Time to Recurrence

  2 years

• Progression Rate at 2 Years

  2 years

• Time to Progression

  2 years

• Number of Recurrences Per Patient

  2 years

• Disease-Free Interval

  2 years

Study Arms (2)

Apaziquone

EXPERIMENTAL

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

Drug: Apaziquone; Procedure: TURBT

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Procedure: TURBT

Interventions

Apaziquone DRUG

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

Also known as: EOquin®, Qapzola

Apaziquone

Placebo DRUG

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

Placebo

TURBT PROCEDURE

TransUrethral Resection of the Bladder Tumor

Apaziquone; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All of the following questions must be answered "Yes" in order for the patient to participate in the study.
• 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 tumor 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?

You may not qualify if:

• All of the following questions must be answered "No" in order for the patient to participate in the study.
• Does the patient have more than 5 bladder tumors?
• Does any single bladder tumor exceed 3.5 cm in diameter?
• Does the patient have a single, primary bladder tumor \<0.5 cm and has no previous diagnosis of bladder cancer?
• Has the patient ever received EOquin(r)?
• Does the patient have, or has the patient ever had, any bladder tumor known to be other than tumor 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 109/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 screening hemoglobin \< 10 mg/dL, a screening absolute neutrophil count \< 1.5 x 109/L?
• 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?

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (77)

Advanced Urology Medical Center Clinical Trials

Anaheim, California, 92801, United States

Location

Hal J. Bashein, D.O.

West Palm Beach, Florida, 33407, United States

Location

Urology Enterprises

Marietta, Georgia, 30060, United States

Location

North Fulton Urology

Roswell, Georgia, 30076, United States

Location

Hines VA Hospital

Hines, Illinois, 60141, United States

Location

The Urology Center

Slidell, Louisiana, 70458, United States

Location

Chesapeake Urology Research Associates

Baltimore, Maryland, 21237, United States

Location

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

PharmaTrials, Inc. - Male & Female Urology

Hillsborough, New Jersey, 08844, United States

Location

PharmaTrials, Inc.

Hillsborough, New Jersey, 08844, United States

Location

Medical & Clinical Research Associates, LLC

Bay Shore, New York, 11706, United States

Location

Urology Associates, PC

Manhasset, New York, 11030, United States

Location

North Shore - LIJ Health System - The Arthur Smith Institute for Urology

New Hyde Park, New York, 11040, United States

Location

Alliance Urology Specialists

Greensboro, North Carolina, 27403, United States

Location

Piedmont Medical Research

Winston-Salem, North Carolina, 27103, United States

Location

Center for Urologic Care

Bryn Mawr, Pennsylvania, 19010, United States

Location

Medical University of South Carolina, Dept. of Urology

Charleston, South Carolina, 29425, United States

Location

Urology Associates of South Texas

McAllen, Texas, 78503, United States

Location

Salt Lake Research

Salt Lake City, Utah, 84107, United States

Location

Adult and Pediatric Urologists

Alexandria, Virginia, 22304, United States

Location

Prostate Cancer Institute

Calgary, Alberta, T2V4R6, Canada

Location

Lintor Medical, Inc.

North Vancouver, British Columbia, V7L2P7, Canada

Location

Andreou Research

Surrey, British Columbia, V3V1N1, Canada

Location

Can-Med Clinical Research, Inc

Victoria, British Columbia, V8T5G1, Canada

Location

G. Steinhoff Clinical Research

Victoria, British Columbia, V8V3N1, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H2Y9, Canada

Location

The Male/Female Health and Research Center - Royal Court Medical Centre

Barrie, Ontario, L4M7G1, Canada

Location

Brantford Urology Research

Brantford, Ontario, N3R4N3, Canada

Location

G. Kenneth Jansz Medicine Professional Corporation

Burlington, Ontario, L7N3V2, Canada

Location

Urology Resource Centre

Burlington, Ontario, L7S1V2, Canada

Location

Kingston General Hospital / Queen's University

Kingston, Ontario, K7L3J7, Canada

Location

Urology Associates, Urologic Medical Research

Kitchener, Ontario, N2N2B9, Canada

Location

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

Mor Urology, Inc.

Newmarket, Ontario, L3X1W1, Canada

Location

Dr. Bernard Goldfarb

North Bay, Ontario, P1B7K8, Canada

Location

Stanley Flax Medical Professional Corporation

North York, Ontario, M3B3S6, Canada

Location

The Fe/Male Health Centre

Oakville, Ontario, L6H3P1, Canada

Location

Orillia Urology Associates

Orillia, Ontario, L3V7V1, Canada

Location

Urotec

Oshawa, Ontario, L1H7K4, Canada

Location

ADA Medical Ltd.

Peterborough, Ontario, K9J7B3, Canada

Location

AGT Research

Scarborough Village, Ontario, M1P2T7, Canada

Location

Urology & Male Infertility

Scarborough Village, Ontario, M1S4V5, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C5T2, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

University Health Network Princess Margaret Hospital

Toronto, Ontario, M5G2M9, Canada

Location

The Male Health Centre

Toronto, Ontario, M6A3B5, Canada

Location

Saint Joseph Health Center

Toronto, Ontario, M6S4W4, Canada

Location

UroLaval

Laval, Quebec, H7G2E6, Canada

Location

McGill Urology Associates

Montreal, Quebec, H3G1A4, Canada

Location

Ultra-Med, Inc.

Pointe Clare, Quebec, H9R4S3, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H5N4, Canada

Location

Centre hospitalier universitaire de Quebec

Québec, G1R3S3, Canada

Location

Uniwersytecki Szpital Kliniczny

Bialystok, 15-276, Poland

Location

Szpital Wojewódzki w Bielsku-Białej

Bielsko-Biala, 43-316, Poland

Location

Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku

Gdansk, 80-402, Poland

Location

Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu

Inowrocław, 88-100, Poland

Location

Szpital Miejski im. Prof. E. Michałowskiego

Katowice, 40-073, Poland

Location

Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej

Kielce, 25-734, Poland

Location

Szpital Specjalistyczny w Kościerzynie

Kościerzyna, 83-400, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej "Racławicka"

Krakow, 30-017, Poland

Location

Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów

Lodz, 90-549, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

Lublin, 20-954, Poland

Location

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach

Pabianice, 95-200, Poland

Location

Zakład Opieki Zdrowotnej Poznań - Stare Miasto

Poznan, 61-285, Poland

Location

Szpital Kolejowy im. Dr med.. Włodzimierza Roeflera w Pruszkowie

Pruszków, 05-800, Poland

Location

Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3

Rybnik, 44-200, Poland

Location

Wojewódzki Szpital Specjalistyczny W Siedlcach

Siedlce, 08-110, Poland

Location

Pomorska Akademia Medyczna

Szczecin, 70-111, Poland

Location

Wojewódzki Szpital Specjalistyczny im Janusza Korczaka

Słupsk, 76-200, Poland

Location

Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego

Warsaw, 00-416, Poland

Location

Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON

Warsaw, 00-909, Poland

Location

Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń

Warsaw, 02-005, Poland

Location

Centrum Onkologii im. Marii Skodowskiej-Curie

Warsaw, 02-781, Poland

Location

Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie

Warsaw, 04-749, Poland

Location

Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, 50-556, Poland

Location

Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy

Wroclaw, 51-124, Poland

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

apaziquone

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Gajanan Bhat, PhD
• Organization: Spectrum Pharmaceuticals

Gajanan.Bhat@sppirx.com

949-743-9219

Study Officials

• Shanta Chawla, MD

  Spectrum Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 23, 2008
• Study Start: August 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 13, 2017
• Results First Posted: August 15, 2017

Record last verified: 2017-10

Locations

US (21); CA (32); PL (24)