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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00782587 | Study of Immediate Post-Operative Intravesical Instillation of Chemophase® in Patients With Superficial Bladder Cancer | PHASE1 | COMPLETED | 14 | — | — | Oct 1, 2008 | Aug 1, 2009 | Feb 8, 2010 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Single arm, open label, single dose, intravesical instillation of Chemophase (combination of rHuPH20 and mitomycin) for appropriate superficial bladder cancer patients within 6 hours of TURBT. |
| Name | Type | Description |
|---|---|---|
| Chemophase | DRUG | 40 mg mitomycin with 800,000 U rHuPH20 total volume of 40 mL instilled |
Inclusion Criteria: * Patient with histologically confirmed or suspected (based on cystoscopy) initial presentation or recurrence of Stage Ta, T1, or Tis transitional cell bladder cancer of any histological grade requiring TURBT. * Patient believed to be a candidate for immediate post-operative che...