Clinical trial · Interventional
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single Dose Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer (Protocol SPI-611)
NCT00461591CI-TRIAL-00050958completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apaziquone | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| TURBT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Apaziquone
- description
- TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
- interventionNames
- Drug: Apaziquone
- Procedure: TURBT
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
- interventionNames
- Drug: Placebo
- Procedure: TURBT
Primary outcomes (1)
- measure
- Recurrence Rate at 2 Years
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \<0.5 cm? * Has the patient ever received Apaziquone? * Does the patient have, or has the patient ever had, any bladder tumor known to be other than stage Ta or grade G1 or G2 (low grade \[WHO/ISUP classification\])? * Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma? * Does the patient have, or has the patient ever had, carcinoma in situ (CIS)? * Does the patient have an active urinary tract infection? * Does the patient have a bleeding disorder or a screening platelet count \< 100 x 10\^9/L? * Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TURBT under general or spinal anesthesia? * Does the patient have a screening hemoglobin \< 10 mg/dL, a screening absolute neutrophil count \< 1.5 x 10\^9/L or a screening creatinine \> 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?
References
Publications (0)
Data not yet available
No reference posted for this study.