Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as EOquin
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 developed for bladder cancer and bladder neoplasms. It is studied as a single dose intravesical treatment given after transurethral resection of bladder tumor (TURBT) in patients with noninvasive bladder cancer. It is not approved and remains in clinical development.
Apaziquone is being developed by Assertio Holdings, Inc., which trades under the ticker ASRT. The company is the sponsor of the clinical program evaluating the drug in bladder cancer.
Apaziquone is in Phase 3 development. Two completed Phase 3 trials, NCT00598806 and NCT00461591, enrolled 812 and 802 patients respectively. A completed Phase 2 trial, NCT00141531, enrolled 53 patients. The drug is investigational and has not been approved.
Apaziquone has been studied in three completed trials. The Phase 3 trials NCT00598806 (SPI-612) and NCT00461591 (SPI-611) evaluated single dose intravesical apaziquone after TURBT in noninvasive bladder cancer. The Phase 2 trial NCT00141531 evaluated EOquin in high-risk superficial bladder cancer.
Yes, EOquin is an alternative name for apaziquone. The Phase 2 trial NCT00141531 was titled as a study of EOquin in high-risk superficial bladder cancer, referring to the same investigational agent.