Phase 3
N=802
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00461591 ↗Enrolled (actual)
802
Serious AEs
23.8%
Results posted
Aug 2017
Primary outcome: Primary: Recurrence Rate at 2 Years — 112; 121; 183; 150 Participants — p=0.1068
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Apaziquone (Drug); Placebo (Drug); TURBT (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spectrum Pharmaceuticals, Inc
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence Rate at 2 Years |
112; 121; 183; 150 | 0.1068 |
| SECONDARY Time to Recurrence |
18.3; 16.7 | 0.0412 sig |
| SECONDARY Progression Rate at 2 Years |
30; 39; 265; 232 | — |
| SECONDARY Time to Progression |
22.9; 22.0 | — |
| SECONDARY Number of Recurrences Per Patient |
0.6; 0.9 | — |
| SECONDARY Disease Free Interval |
22.9; 22.0 | — |
| SECONDARY Disease Free Survival |
18.0; 16.4 | — |
| SECONDARY Overall Survival |
20.3; 23.7 | — |
Summary
The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.
Eligibility Criteria
Inclusion Criteria: (All questions must be answered YES)
- Has the patient given written informed consent?
- Is the patient at least 18 years old?
- Does the patient have transitional cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2?
- If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
- If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days?
- Is the patient willing and able to abide by the protocol?
Exclusion Criteria: (All questions must be answered NO)
- Does the patient have more than 4 bladder tumors?
- Does any single bladder tumor exceed 3.5 cm in diameter?
- Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor 2 mg/dL?
- Does the patient have a known immunodeficiency disorder?
- Has the patient received any investigational treatment within the past 30 days?
- Is the patient breast feeding?
- Does the patient have a history of interstitial cystitis?
- Does the patient have a history of allergy to red color food dye?
- Has the patient had transitional cell carcinoma of the bladder within the past 4 months?
Data sourced from ClinicalTrials.gov (NCT00461591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.