Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Apaziquone

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

6 weekly multi-instillation of matching placebo in 40mL

Placebo

Show-Li Sun, MD

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.

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

A Phase 3 International, Double-Bind Trial Evaluating Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

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

Proportion of patients with recurrence at or before 24 months

Allergan

Spectrum Pharmaceuticals, Inc

6 weekly multi-instillation of matching placebo in 40 mL

Open Label-Apaziquone

Apaziquone (4 mg in 40 mL)

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

Matching placebo (40 mL)

Placebo: 6 weekly multi-instillation of matching placebo in 40mL

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Gajanan Bhat, PhD

Patients who were in the Double Blind Phase

Time to Recurrence

2-Year Recurrence Rate

Open Label Phase

Double Blind Phase

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 from randomization. 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.

Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer

A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

Time to recurrence is the time from randomization to the date of first histologically confirmed recurrence of bladder cancer (for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo).

Measurement the number of participants with the recurrence at 24 months.

TEAEs will be mainly characterized by the number of treatment emergent adverse events and treatment related AEs that occur or worsen after the first dose of study treatment.

Apaziquone: Apaziquone 4 mg in 40 mL diluent

Apaziquone: Apaziquone in the Double Blind Phase

Placebo

Placebo: Placebo in the Double Blind Phase

Apaziquone 4 mg in 40 mL diluent

Apaziquone in the Double Blind Phase

Placebo

Placebo in the Double Blind Phase

Gender

Safety Analysis Population included all randomized patients in the double blind phase.

Gajanan Bhat

Apaziquone: Apaziquone 4 mg in 40 mL diluent

Apaziquone in the Double Blind Phase

All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase. Participants without recurrence were censored.

All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase.

Recurrence Rate at 24 Months

Participants With Treatment Emergent Adverse Events (TEAEs)

Open Label Phase Apaziquone

4 mg/40 mL, Intravesical instillation, Single dose within 6 hours after TURBT

EO9 (Apaziquone)

40 mL, Intravesical instillation, Single dose within 6 hours after TURBT

Yoshihiro Nambu, M.D., Ph.D.

Woo Ick Jang, M.D., Ph.D.

The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)	NCT01469221	Bladder Cancer	Apaziquone Placebo	18 Years -	Spectrum Pharmaceuticals, Inc
Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)	NCT01469221	Bladder Cancer	Apaziquone Placebo	18 Years -	Spectrum Pharmaceuticals, Inc
Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer	NCT01410565	Bladder Cancer	Apaziquone Placebo	18 Years -	Spectrum Pharmaceuticals, Inc
Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)	NCT01475266	Bladder Cancer	EO9 (Apaziquone... Placebo	20 Years -	Nippon Kayaku Co., Ltd.
Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer	NCT01410565	Bladder Cancer	Apaziquone Placebo	18 Years -	Spectrum Pharmaceuticals, Inc
Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)	NCT01475266	Bladder Cancer	EO9 (Apaziquone... Placebo	20 Years -	Nippon Kayaku Co., Ltd.

Spots Global Cancer Trial Database for eoquin

Every month we try and update this database with for eoquin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for eoquin

Every month we try and update this database with for eoquin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for eoquin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.