Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)

NCT01469221 | Terminated Phase 3 Results DMC

• 2 other identifiers: SPI-10122011-003517-42
• Study Type: interventional
• Target: 47
• Locations: 4 countries
• Sites: 29

Brief Summary

This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double Blind Phase qualification, patients with confirmed eligibility will be randomized to receive either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo cystoscopic and safety assessments every 3 months for 24 months. Patients with histologic evidence of recurrent disease during the study will be treated according to current treatment guidelines or local standard of care. Safety and efficacy assessments will be performed at 3 month intervals for all randomized patients throughout the study. Patients who receive single dose of apaziquone immediately following TURBT and are not eligible for randomization will be followed for 3 months by cystoscopic exam and safety assessments.

Conditions

Bladder Cancer

Keywords

Bladder Cancer; Non-Muscle Invasive Bladder Cancer; NMIBC; Apaziquone; EOquin; GU Cancer; TURBT

Outcome Measures

Primary Outcomes (1)

• Time to Recurrence

  Time from randomization to the date of first histologically confirmed recurrence of bladder cancer

  24 Months

Secondary Outcomes (1)

• 2-Year Recurrence Rate

  24 Months

Study Arms (2)

Apaziquone

EXPERIMENTAL

Apaziquone (4 mg in 40 mL)

Drug: Apaziquone

Placebo

PLACEBO COMPARATOR

Matching placebo (40 mL)

Drug: Placebo

Interventions

Apaziquone DRUG

6 weekly multi-instillation of Apaziquone 4 mg in 40 mL

Also known as: EoQuin, EO9

Apaziquone

Placebo DRUG

6 weekly multi-instillation of matching placebo in 40mL

Placebo

Eligibility Criteria

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

You may qualify if:

• Has the patient given written informed consent and is the patient willing and able to abide by the protocol?
• Is the patient 18 years old or above?
• If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
• Does the female patient of childbearing potential have a negative serum pregnancy test at screening?
• Does the patient with clinically apparent primary or recurrent low grade Ta NMIBC have :
• multiple tumors (2-7)
• No single Tumor \> 3 cm
• No history / evidence of Tis
• Or does the patient with clinically apparent primary or recurrent high grade Ta NMIBC have:
• A single tumor that is ≤ 3 cm
• No history / evidence of Tis
• Is the patient able to retain bladder instillations for a minimum of 60 minutes (± 6 minutes)?
• Did the patient have upper urinary tract evaluation to exclude urothelial carcinoma, hydronephrosis or renal cell carcinoma or other renal cancers in the 6 months prior to study screening?
• Is patient's urethra (including prostatic urethra in men) endoscopically free of any visible TCC?
• For patients with recurrent tumor, did the patient have at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and the time of screening?

You may not qualify if:

• Has the patient received any previous pelvic radiotherapy (includes external beam and/or brachytherapy)?
• Has the patient ever received apaziquone?
• Has the patient received an induction course (completed 5 of 6 scheduled weekly instillations) of intravesical BCG (± interferon) with the last dose given less than 12 months ago?
• Has the patient had any prior intravesical chemotherapy, exclusive of single-dose adjuvant intravesical chemotherapy immediately post-TURBT?
• Does the patient have a history of urinary retention or a post void residual ≥ 250 cc by bladder scan or ultrasound (post void residual test may be repeated up to 3 times)?
• Does the patient have or has the patient had any bladder tumor with histology other than transitional cell carcinoma?
• Does the patient have or has the patient had micro-papillary transitional cell carcinoma?
• If the patient has recurrent papillary disease of the bladder, has the pathology been anything other than pTa in the past?
• Does the patient have an active urinary tract infection confirmed by culture or a documented history of recurrent UTI (≥ 6 for females and ≥2 for males per year) in the prior 2 years?
• Does the patient have a bleeding disorder or a screening platelet count \< 50 x 109/L?
• Does the patient have a screening hemoglobin \< 10 g/dL?
• Does the male patient have a screening serum PSA \> 10 ng/mL?
• Does the patient have a history of Acquired Immunodeficiency Syndrome or HIV positive?
• Does the patient have a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g., uncontrolled diabetes, decompensated congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, or an active uncontrolled infection), which could compromise participation, compliance with scheduled visits and/or completion of the study?
• Has the patient participated in an investigational protocol within the past 90 days?

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead
• Allergan: collaborator

Study Sites (29)

Tower Research Institute

Los Angeles, California, 90048, United States

Location

Department of Urology, University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Somerset Urological Associates, PA

Somerville, New Jersey, 08876, United States

Location

Associated Medical Professionals of New York, PLLC

Oneida, New York, 13421, United States

Location

Male and Female Urology

Staten Island, New York, 10314, United States

Location

Associated Medical Professionals of New York, PLLC

Syracuse, New York, 13210, United States

Location

Alliance Urology Specialists

Greensboro, North Carolina, 27403, United States

Location

Nemocnice Jablonec nad Nisou, Urologické oddělení

Jablonec nad Nisou, 466 60, Czechia

Location

Fakultní Thomayerova nemocnice s poliklinikou Urologické oddělení

Prague, 14059, Czechia

Location

Szpital Miejski im. Prof. E. Michałowskiego

Katowice, 40-073, Poland

Location

CenterMed Kraków sp z o.o.

Krakow, 31-530, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej-Centrum Medyczne Szpital Świętej Rodziny sp z o.o.

Lodz, 90-302, Poland

Location

Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lublinie, Oddział Urologii i Onkologii Urologicznej

Lublin, 20-718, Poland

Location

Nieubliczny Zakład Opieki Zdrowotnej Europejskie Centrum Zdrowia Otwock im. Fryderyka Chopina Nieubliczny Zakład Opieki Zdrowotnej

Otwock, 05-400, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej Pabianickie Centrum Medyczne

Pabianice, 95-200, 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 Bielański im. ks. J. Popiełuszki Samodzielny Publiczny Zakład Opieki Zdrowotnej

Warsaw, 01-809, Poland

Location

Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń

Warsaw, 02-005, Poland

Location

Międzyleski Szpital Specjalistyczny w Warszawie Oddział Urologii

Warsaw, 04-749, Poland

Location

Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy

Wroclaw, 51-124, Poland

Location

Univerzitná nemocnica L. Pasteura Košice Univerzitná nemocnica L. Pasteura Košice

Košice, 041 66, Slovakia

Location

Univerzitná nemocnica Martin Urologická klinika

Martin, 036 59, Slovakia

Location

Fakultná nemocnica s poliklinikou J. A. Reimana Prešov Urologická klinika

Prešov, 081 81, Slovakia

Location

Fakultná nemocnica s poliklinikou Žilina Urologické oddelenie

Žilina, 012 07, Slovakia

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive 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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

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

Gajanan.Bhat@sppirx.com

949-743-9219

Study Officials

• Show-Li Sun, MD

  Spectrum Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: November 8, 2011
• First Posted: November 10, 2011
• Study Start: January 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 15, 2017
• Results First Posted: December 15, 2017

Record last verified: 2017-10

Locations

US (7); CZ (2); PL (16); SL (4)