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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apaziquone
Placebo
TURBT
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Noninvasive Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Exclusion Criteria:

All of the following questions must be answered "No" in order for the patient to participate in the study.

  1. Does the patient have more than 5 bladder tumors?
  2. Does any single bladder tumor exceed 3.5 cm in diameter?
  3. Does the patient have a single, primary bladder tumor <0.5 cm and has no previous diagnosis of bladder cancer?
  4. Has the patient ever received EOquin(r)?
  5. 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])?
  6. Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma?
  7. Does the patient have, or has the patient ever had, carcinoma in situ (CIS)?
  8. Does the patient have an active urinary tract infection?
  9. Does the patient have a bleeding disorder or a screening platelet count < 100 x 109/L?
  10. Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TURBT under general or spinal anesthesia?
  11. Does the patient have screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 109/L?
  12. Does the patient have a known immunodeficiency disorder?
  13. Has the patient received any investigational treatment within the past 30 days?
  14. Is the patient breast feeding?
  15. Does the patient have a history of interstitial cystitis?
  16. Does the patient have a history of allergy to red color food dye?
  17. Has the patient had transitional cell carcinoma of the bladder within the past 4 months?

Sites / Locations

  • Advanced Urology Medical Center Clinical Trials
  • Hal J. Bashein, D.O.
  • Urology Enterprises
  • North Fulton Urology
  • Hines VA Hospital
  • The Urology Center
  • Chesapeake Urology Research Associates
  • Chesapeake Urology Research Associates
  • William Beaumont Hospital
  • PharmaTrials, Inc. - Male & Female Urology
  • PharmaTrials, Inc.
  • Medical & Clinical Research Associates, LLC
  • Urology Associates, PC
  • North Shore - LIJ Health System - The Arthur Smith Institute for Urology
  • Alliance Urology Specialists
  • Piedmont Medical Research
  • Center for Urologic Care
  • Medical University of South Carolina, Dept. of Urology
  • Urology Associates of South Texas
  • Salt Lake Research
  • Adult and Pediatric Urologists
  • Prostate Cancer Institute
  • Lintor Medical, Inc.
  • Andreou Research
  • Can-Med Clinical Research, Inc
  • G. Steinhoff Clinical Research
  • Queen Elizabeth II Health Sciences Centre
  • The Male/Female Health and Research Center - Royal Court Medical Centre
  • Brantford Urology Research
  • G. Kenneth Jansz Medicine Professional Corporation
  • Urology Resource Centre
  • Kingston General Hospital / Queen's University
  • Urology Associates, Urologic Medical Research
  • London Health Sciences Centre
  • Mor Urology, Inc.
  • Dr. Bernard Goldfarb
  • Stanley Flax Medical Professional Corporation
  • The Fe/Male Health Centre
  • Orillia Urology Associates
  • Urotec
  • ADA Medical Ltd.
  • AGT Research
  • Urology & Male Infertility
  • Toronto East General Hospital
  • Sunnybrook Health Sciences Centre
  • University Health Network Princess Margaret Hospital
  • The Male Health Centre
  • Saint Joseph Health Center
  • UroLaval
  • McGill Urology Associates
  • Ultra-Med, Inc.
  • Centre Hospitalier Universitaire de Sherbrooke
  • Centre hospitalier universitaire de Quebec
  • Uniwersytecki Szpital Kliniczny
  • Szpital Wojewódzki w Bielsku-Białej
  • Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku
  • Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu
  • Szpital Miejski im. Prof. E. Michałowskiego
  • Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej
  • Szpital Specjalistyczny w Kościerzynie
  • Niepubliczny Zakład Opieki Zdrowotnej "Racławicka"
  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
  • Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach
  • Zakład Opieki Zdrowotnej Poznań - Stare Miasto
  • Szpital Kolejowy im. Dr med.. Włodzimierza Roeflera w Pruszkowie
  • Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3
  • Wojewódzki Szpital Specjalistyczny W Siedlcach
  • Pomorska Akademia Medyczna
  • Wojewódzki Szpital Specjalistyczny im Janusza Korczaka
  • Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
  • Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON
  • Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń
  • Centrum Onkologii im. Marii Skodowskiej-Curie
  • Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie
  • Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu
  • Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy
  • Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apaziquone

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Recurrence
The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.
Progression Rate at 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
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
The number of histologically confirmed recurrences during the course of the study.
Disease-Free Interval
The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause
Disease-Free Survival
The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause
Overall Survival
The number of months from randomization to death from any cause.

Full Information

First Posted
January 11, 2008
Last Updated
October 10, 2017
Sponsor
Spectrum Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00598806
Brief Title
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)
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-612)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2007 (Actual)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Noninvasive Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
812 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apaziquone
Arm Type
Experimental
Arm Description
TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Intervention Type
Drug
Intervention Name(s)
Apaziquone
Other Intervention Name(s)
EOquin®, Qapzola
Intervention Description
A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A single intravesical dose of placebo instilled into the bladder post-TURBT
Intervention Type
Procedure
Intervention Name(s)
TURBT
Intervention Description
TransUrethral Resection of the Bladder Tumor
Primary Outcome Measure Information:
Title
Recurrence Rate at 2 Years
Description
The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Time to Recurrence
Description
The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.
Time Frame
2 years
Title
Progression Rate at 2 Years
Description
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 Frame
2 years
Title
Time to Progression
Description
The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.
Time Frame
2 years
Title
Number of Recurrences Per Patient
Description
The number of histologically confirmed recurrences during the course of the study.
Time Frame
2 years
Title
Disease-Free Interval
Description
The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause
Time Frame
2 years
Title
Disease-Free Survival
Description
The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause
Time Frame
2 years
Title
Overall Survival
Description
The number of months from randomization to death from any cause.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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? Exclusion Criteria: 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? 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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shanta Chawla, MD
Organizational Affiliation
Spectrum Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Urology Medical Center Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Hal J. Bashein, D.O.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Urology Enterprises
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
North Fulton Urology
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Hines VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
The Urology Center
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
PharmaTrials, Inc. - Male & Female Urology
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
PharmaTrials, Inc.
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Medical & Clinical Research Associates, LLC
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
Urology Associates, PC
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
North Shore - LIJ Health System - The Arthur Smith Institute for Urology
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Alliance Urology Specialists
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Piedmont Medical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Center for Urologic Care
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Medical University of South Carolina, Dept. of Urology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Urology Associates of South Texas
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Salt Lake Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Adult and Pediatric Urologists
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Prostate Cancer Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V4R6
Country
Canada
Facility Name
Lintor Medical, Inc.
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L2P7
Country
Canada
Facility Name
Andreou Research
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V1N1
Country
Canada
Facility Name
Can-Med Clinical Research, Inc
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T5G1
Country
Canada
Facility Name
G. Steinhoff Clinical Research
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V3N1
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2Y9
Country
Canada
Facility Name
The Male/Female Health and Research Center - Royal Court Medical Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M7G1
Country
Canada
Facility Name
Brantford Urology Research
City
Brantford
State/Province
Ontario
ZIP/Postal Code
N3R4N3
Country
Canada
Facility Name
G. Kenneth Jansz Medicine Professional Corporation
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N3V2
Country
Canada
Facility Name
Urology Resource Centre
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7S1V2
Country
Canada
Facility Name
Kingston General Hospital / Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L3J7
Country
Canada
Facility Name
Urology Associates, Urologic Medical Research
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N2B9
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5W9
Country
Canada
Facility Name
Mor Urology, Inc.
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3X1W1
Country
Canada
Facility Name
Dr. Bernard Goldfarb
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B7K8
Country
Canada
Facility Name
Stanley Flax Medical Professional Corporation
City
North York
State/Province
Ontario
ZIP/Postal Code
M3B3S6
Country
Canada
Facility Name
The Fe/Male Health Centre
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H3P1
Country
Canada
Facility Name
Orillia Urology Associates
City
Orillia
State/Province
Ontario
ZIP/Postal Code
L3V7V1
Country
Canada
Facility Name
Urotec
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H7K4
Country
Canada
Facility Name
ADA Medical Ltd.
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J7B3
Country
Canada
Facility Name
AGT Research
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P2T7
Country
Canada
Facility Name
Urology & Male Infertility
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1S4V5
Country
Canada
Facility Name
Toronto East General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C5T2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
University Health Network Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
The Male Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A3B5
Country
Canada
Facility Name
Saint Joseph Health Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6S4W4
Country
Canada
Facility Name
UroLaval
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7G2E6
Country
Canada
Facility Name
McGill Urology Associates
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada
Facility Name
Ultra-Med, Inc.
City
Pointe Clare
State/Province
Quebec
ZIP/Postal Code
H9R4S3
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
Facility Name
Centre hospitalier universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1R3S3
Country
Canada
Facility Name
Uniwersytecki Szpital Kliniczny
City
Białystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Szpital Wojewódzki w Bielsku-Białej
City
Bielsko-Biała
ZIP/Postal Code
43-316
Country
Poland
Facility Name
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku
City
Gdańsk
ZIP/Postal Code
80-402
Country
Poland
Facility Name
Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu
City
Inowrocław
ZIP/Postal Code
88-100
Country
Poland
Facility Name
Szpital Miejski im. Prof. E. Michałowskiego
City
Katowice
ZIP/Postal Code
40-073
Country
Poland
Facility Name
Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Szpital Specjalistyczny w Kościerzynie
City
Kościerzyna
ZIP/Postal Code
83-400
Country
Poland
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej "Racławicka"
City
Kraków
ZIP/Postal Code
30-017
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach
City
Pabianice
ZIP/Postal Code
95-200
Country
Poland
Facility Name
Zakład Opieki Zdrowotnej Poznań - Stare Miasto
City
Poznań
ZIP/Postal Code
61-285
Country
Poland
Facility Name
Szpital Kolejowy im. Dr med.. Włodzimierza Roeflera w Pruszkowie
City
Pruszków
ZIP/Postal Code
05-800
Country
Poland
Facility Name
Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny W Siedlcach
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Pomorska Akademia Medyczna
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im Janusza Korczaka
City
Słupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
City
Warszawa
ZIP/Postal Code
00-416
Country
Poland
Facility Name
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń
City
Warszawa
ZIP/Postal Code
02-005
Country
Poland
Facility Name
Centrum Onkologii im. Marii Skodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy
City
Wrocław
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów
City
Łódź
ZIP/Postal Code
90-549
Country
Poland

12. IPD Sharing Statement

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

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