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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01454089 | A Phase 2 Study Comparing Chemotherapy in Combination With OGX-427 or Placebo in Patients With Bladder Cancer | PHASE2 | COMPLETED | 183 | — | — | Oct 1, 2011 | Nov 1, 2014 | Oct 7, 2016 | 55 | United States, Canada +5 |
OS is defined as the time from randomization to death from any cause; OS was censored on date of last contact for participants still alive at time of analysis.
| Arm | Type | Description |
|---|---|---|
| OGX-427 600 mg | EXPERIMENTAL | Standard chemotherapy (gemcitabine and cisplatin) in combination with OGX-427 (600 mg) |
| OGX-427 1000 mg | EXPERIMENTAL | Standard chemotherapy (gemcitabine and cisplatin) in combination with OGX-427 (1000 mg) |
| Placebo | ACTIVE_COMPARATOR | Standard chemotherapy (gemcitabine and cisplatin) in combination with placebo |
| Name | Type | Description |
|---|---|---|
| OGX-427 600 mg | DRUG | Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (600 mg IV) on Days 1, 8 and 15 of each 21-day cycle. |
| OGX-427 1000 mg | DRUG | Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (1000 mg IV) on Days 1, 8 and 15 of each 21-day cycle. |
| Placebo | DRUG | Patients will receive three loading doses of placebo within a 9-day period. Following the loading dose period, patients will receive weekly placebo infusions (IV) on Days 1, 8 and 15 of each 21-day cycle. |
| Gemcitabine | DRUG | Patients will receive gemcitabine (1000 mg/m\^2) for up to 6 cycles administered IV on Days 1 and 8 of each 21-day cycle following Study Drug infusion. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug. |
| Cisplatin | DRUG | Following the administration of gemcitabine on Day 1, cisplatin (70 mg/m\^2) will be administered IV for up to 6 cycles. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug. |
| Carboplatin | DRUG | Following the administration of gemcitabine on Day 1, cisplatin (70 mg/m\^2) is to be administered IV for up to 6 cycles; however, carboplatin could be substituted for cisplatin for some unacceptable toxicities. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug. |
Inclusion Criteria: 1. Age ≥ 18 years at the time of consent 2. Histologically documented metastatic or locally inoperable advanced transitional cell carcinoma (TCC) of the urinary tract (bladder, urethra, ureter and renal pelvis) (T4b, N2, N3 or M1 disease) NOTE: Certain mixed histologies that are...