Status:
TERMINATED
Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer
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
- Open Phase
- 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
- 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
- Open Phase
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01410565
Start Date
July 1 2011
End Date
March 1 2014
Last Update
December 13 2016
Active Locations (47)
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1
Valley Urologic Associates
Glendale, Arizona, United States, 85308
2
Precision Trials, LLC
Phoenix, Arizona, United States, 85032
3
South Orange County Medical Research Center
Laguna Woods, California, United States, 92653
4
The Urology Center of Colorado
Denver, Colorado, United States, 80211