Status:
TERMINATED
Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Collaborating Sponsors:
Allergan
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria (for Open Label):
- 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?
- 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?
- Exclusion Criteria (for Open Label):
- 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?
- 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?
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01469221
Start Date
January 1 2012
End Date
April 1 2013
Last Update
December 15 2017
Active Locations (29)
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1
Tower Research Institute
Los Angeles, California, United States, 90048
2
Department of Urology, University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
3
Somerset Urological Associates, PA
Somerville, New Jersey, United States, 08876
4
Associated Medical Professionals of New York, PLLC
Oneida, New York, United States, 13421