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Sponsored by: |
Spectrum Pharmaceuticals, Inc |
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Information provided by: | Spectrum Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00598806 |
This is a multicenter, randomized, placebo-controlled, double-blind, study. Following TUR-BT, eligible patients will be randomized to receive either intravesical EOquin® (Apaziquone) or matching placebo instilled within 6 hours of surgery. Patients will be seen for a postoperative follow-up exam 21±10 days after the TUR. At this time, the pathology report will be reviewed. If the histology of the patient's tumor is Ta, G1-G2 (low grade [WHO/ISUP classification]), then the patient will receive no further treatment and will be observed cystoscopically every three months through year two for tumor recurrence and progression. If the histology of the patient's tumor is other than Ta, G1-G2 (low grade [WHO/ISUP classification]), then the patient will receive further treatment in accordance with current treatment guidelines, following which the patient will be followed up cystoscopically every three months through year two for tumor recurrence and progression.
The primary endpoint is to evaluate the recurrence rate at 2 years in randomized patients with tumor histology Ta, G1-G2 who receive TUR-BT plus EOquin® versus those who receive TUR-BT plus placebo.
Condition | Intervention | Phase |
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Bladder Cancer |
Drug: EOquin® (Apaziquone) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Placebo-Controlled, Double-Blind Phase 3 Trial of Single-Dose Intravesical EOquin® as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer |
Estimated Enrollment: | 674 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo
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Drug: EOquin® (Apaziquone)
4mg in 40 mL for intravesical instillation
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2: Experimental
EOquin® (Apaziquone)
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Drug: EOquin® (Apaziquone)
4mg in 40 mL for intravesical instillation
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All of the following questions must be answered "Yes" in order for the patient to participate in the study.
Exclusion Criteria:
All of the following questions must be answered "No" in order for the patient to participate in the study.
Contact: Shanta Chawla, MD | (949) 788-6700 ext 257 | schawla@spectrumpharm.com |
Contact: Deborah Robbins | (949) 788-6700 ext 235 | drobbins@spectrumpharm.com |
United States, Florida | |
Hal J. Bashein, D.O. | Recruiting |
West Palm Beach, Florida, United States, 33407 | |
Contact: Sara Fonseca 561-848-8700 | |
Principal Investigator: Hal J Bashein, DO | |
United States, Georgia | |
Urology Enterprises | Recruiting |
Marietta, Georgia, United States, 30060 | |
Contact: Becky Hippensteel 770-428-6478 | |
Principal Investigator: Ronald Roper, MD | |
United States, Louisiana | |
The Urology Center | Recruiting |
Slidell, Louisiana, United States, 70458 | |
Contact: Nikrad Shahnavaz 504-952-3162 | |
Principal Investigator: Mahmoud Daftary, MD |
Responsible Party: | Spectrum Pharmaceuticals ( Spectrum Pharmaceuticals ) |
Study ID Numbers: | SPI-612 |
Study First Received: | January 11, 2008 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00598806 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Noninvasive Bladder Cancer |
Urinary Tract Neoplasm Cystocele Urologic Diseases Urinary Bladder Diseases Adjuvants, Immunologic |
Urinary Bladder Neoplasms Urogenital Neoplasms Bladder Neoplasm Urologic Neoplasms EO 9 |
Neoplasms Neoplasms by Site Urologic Diseases Urinary Bladder Diseases |
Urinary Bladder Neoplasms Urogenital Neoplasms Urologic Neoplasms |