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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04498702 | Study of Continuous APL-1202 Treatment in Subjects With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Relapsed From Intravesical Chemo/BCG Therapy | PHASE2 | COMPLETED | 41 | — | — | May 13, 2014 | Jan 18, 2017 | Aug 13, 2020 | - | — |
| Arm | Type | Description |
|---|---|---|
| APL-1202 treatment | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| APL-1202 treatment | DRUG | A modified 3+3 design was employed: The dose was started at 300 mg and increased to 450 mg, 600 mg and 750 mg if there was no dose-limiting toxicity (DLT) in 3 subjects after 4-week consecutive administration of APL-1202. When the dose-escalation study was in progress, the doses for any newly enrolled subjects would be the starting dose or the highest dose confirmed with no DLT by the dose-escalation cohort at the time of enrollment. When the MTD or the 750 mg daily dose was attained as a safe dose, the dose for all subjects in the study or subsequently enrolled subjects would be MTD or 750 mg/day. |
Inclusion Criteria: 1. Well-informed with this trial and willing to sign the informed consent form; 2. Subjects have been clinically and histologically proven as relapsed high-risk non-muscle-invasive urothelial carcinoma of the bladder through clinical cystoscopy, urine cytology and pathological e...