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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01578655 | Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer | PHASE3 | COMPLETED | 630 | — | — | Aug 1, 2012 | Jul 1, 2016 | Oct 12, 2016 | 94 | United States, Australia +6 |
To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone).
To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) and identified as having poor prognosis is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone) and identified as having poor prognosis.
| Arm | Type | Description |
|---|---|---|
| Cabazitaxel plus Custirsen | EXPERIMENTAL | cabazitaxel, prednisone, and custirsen sodium |
| Cabazitaxel | ACTIVE_COMPARATOR | cabazitaxel and prednisone |
| Name | Type | Description |
|---|---|---|
| cabazitaxel | DRUG | Cabazitaxel (25mg/m² IV) is administered on day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles |
| prednisone | DRUG | Prednisone (10 mg PO) is administered daily until disease progression, unacceptable toxicity, or completion of 10 cycles |
| custirsen sodium | DRUG | Custirsen is administered as 3 loading doses (640 mg IV each) within 9 days, followed by weekly custirsen (640 mg IV) during each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles |
Inclusion Criteria: * Histological or cytological diagnosis of adenocarcinoma of the prostate * Metastatic disease on chest, abdominal, or pelvic CT scan and/or bone scan * Previous first-line treatment for CRPC with a docetaxel-containing regimen * Current progressive disease * Increasing serum PS...