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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT01410565

Run by

Spectrum Pharmaceuticals, Inc

People needed

66

Starts

2011-07-01

Expected to finish

2014-03-01

Last updated by the study team

2016-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Open Phase Inclusion Criteria:
• 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?
• 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?
• Has the male patient with a prostate specific antigen (PSA) between 4 and 10 ng/mL had a diagnostic evaluation that reasonably excludes the diagnosis of prostate cancer in the opinion of the Investigator?
• Double-Blind Phase Inclusion Criteria:
• Was all visible tumor resected at the initial TURBT?
• Does Central Pathology review of the patient's bladder tumor confirm:
• Low grade Ta disease for multiple tumors (2 - 7) or
• High Grade Ta disease for single tumor
• No microscopic evidence of lymphovascular invasion and/or evidence of tumor thromboemboli

You may not qualify if…

• Open Phase Exclusion Criteria:
• 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 mg/dL?
• Does the male patient have a 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?
• Is the patient pregnant or breast feeding?
• Does the patient have a life expectancy of <3 years?
• Has the patient had any other malignancy or received therapy for any malignancy in the last five years except
• non-melanoma skin tumors
• stage 0 (in situ) cervical carcinoma
• undetectable PSA for ≥1 year following definitive therapy for localized prostate cancer?
• Does the patient have documented vesicoureteral reflux or an indwelling ureteral stent?
• Does the patient have tumor in a bladder diverticulum?
• Does the patient have a known allergy to red color food dye?

Where it is running

• Valley Urologic Associates — Glendale, Arizona, United States
• Precision Trials, LLC — Phoenix, Arizona, United States
• South Orange County Medical Research Center — Laguna Woods, California, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Connecticut Clinical Research Center — Middlebury, Connecticut, United States
• Urology Enterprises — Marietta, Georgia, United States
• North Idaho Urology — Coeur d'Alene, Idaho, United States
• Idaho Urologic Institute, P.A. — Meridian, Idaho, United States
• Northeast Indiana Research, LLC — Fort Wayne, Indiana, United States
• First Urology, PSC — Jeffersonville, Indiana, United States
• Regional Urology, LLC — Shreveport, Louisiana, United States
• Anne Arundel Urology — Annapolis, Maryland, United States
• Spectrum Health Medical Group — Grand Rapids, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Five Valleys Urology — Missoula, Montana, United States
• Delaware Valley Urology, LLC - Voorhees — Voorhees Township, New Jersey, United States
• Delaware Valley Urology, LLC-Westampton — Woodlane, New Jersey, United States
• University Urology Associates — New York, New York, United States
• Urology Associates of Rochester, LLC — Rochester, New York, United States
• TriState Urologic Services PSC, Inc. — Cincinnati, Ohio, United States
• Urologic Consultants of Southeastern Pennsylvania, LLP — Bala-Cynwyd, Pennsylvania, United States
• Urology Health Specialists — Bryn Mawr, Pennsylvania, United States
• Urological Associates of Lancaster — Lancaster, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Urology Associates of South Texas — McAllen, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.