Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00598806 | Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612) | PHASE3 | COMPLETED | 812 | — | — | Aug 1, 2007 | Jan 1, 2012 | Nov 13, 2017 | 77 | United States, Canada +1 |
| NCT00461591 | Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611) | PHASE3 | COMPLETED | 802 | — | — | Apr 1, 2007 | Jan 1, 2012 | Mar 30, 2021 | 74 | United States |
The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.
| Arm | Type | Description |
|---|---|---|
| Apaziquone | EXPERIMENTAL | TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT |
| Placebo | PLACEBO_COMPARATOR | TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT |
| Name | Type | Description |
|---|---|---|
| Apaziquone | DRUG | A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT |
| Placebo | DRUG | A single intravesical dose of placebo instilled into the bladder post-TURBT |
| TURBT | PROCEDURE | TransUrethral Resection of the Bladder Tumor |
Inclusion Criteria: All of the following questions must be answered "Yes" in order for the patient to participate in the study. 1. Has the patient given written informed consent? 2. Is the patient at least 18 years old? 3. Does the patient have transitional cell carcinoma of the bladder with clini...