Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Apaziquone · 3 trials · 2 indications
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...
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Apaziquone is an investigational small molecule being studied for the treatment of bladder cancer, specifically bladder neoplasms. It is administered intravesically, meaning directly into the bladder, and has been evaluated in clinical trials for noninvasive bladder cancer in patients undergoing transurethral resection of bladder tumor (TURBT).
Apaziquone is being developed by Assertio Holdings, Inc., a company traded on NASDAQ under the ticker symbol ASRT. The company has sponsored clinical trials of the drug for bladder cancer indications.
Apaziquone has completed Phase 3 clinical trials for bladder cancer. It is an investigational drug and has not been approved by the FDA. Two Phase 3 trials, SPI-611 and SPI-612, have been completed, along with an earlier Phase 2 trial.
Apaziquone has been studied in three completed clinical trials: NCT00141531, a Phase 2 trial in high-risk superficial bladder cancer in the Netherlands; NCT00461591 (SPI-611), a Phase 3 trial in the United States; and NCT00598806 (SPI-612), a Phase 3 trial in the United States, Canada, and Poland. All trials involved patients with bladder cancer.
Apaziquone is a small molecule that acts as a bioreductive agent. It is activated within cells to form a cytotoxic compound that damages DNA, leading to cell death. This mechanism is particularly relevant in bladder cancer, where the drug is delivered directly into the bladder to target tumor cells.