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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01188187 | Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer | PHASE3 | COMPLETED | 1,022 | — | — | Nov 1, 2010 | Jun 1, 2014 | Oct 14, 2016 | 140 | United States, Belgium +10 |
| NCT00327340 | Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC | PHASE2 | COMPLETED | 70 | — | — | Jul 1, 2006 | Oct 1, 2010 | Oct 5, 2012 | 10 | Canada |
Time from the date of randomization to death from any cause. After stopping treatment, patients were followed every 4 weeks until disease progression and then followed every 12 weeks until death.
Safety and tolerability were based on Adverse Events (AE) and Serious Adverse Events (SAE) graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). The CTCAE has 5 grades with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1=Mild AE; Grade 2=Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE; and Grade 5=Death related to AE.
| Arm | Type | Description |
|---|---|---|
| Custirsen, Docetaxel, Prednisone | EXPERIMENTAL | Three doses of 640 mg custirsen administered intravenously (IV) as a loading dose between Days -9 to -1. Custirsen, 640 mg, given IV weekly on Days 1, 8, and 15 of each 21-day cycle. Docetaxel (75 mg/M\^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration). Treatment continues for 10 cycles or until unacceptable toxicity or disease progression. |
| Docetaxel, Prednisone | ACTIVE_COMPARATOR | Docetaxel (75 mg/M\^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration). Treatment continues for 10 cycles or until unacceptable toxicity or disease progression. |
| OGX-011 / mitoxantrone/prednisone | EXPERIMENTAL | OGX-011 / mitoxantrone/prednisone: OGX-011 administered in combination with mitoxantrone and prednisone |
| OGX-011/docetaxel/prednisone | EXPERIMENTAL | OGX-011/docetaxel/prednisone: OGX-011 administered in combination with docetaxel and prednisone |
| Name | Type | Description |
|---|---|---|
| Custirsen | DRUG | - |
| Docetaxel | DRUG | - |
| Prednisone | DRUG | - |
| Dexamethasone | DRUG | Dexamethasone 8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration to reduce the incidence and severity of hypersensitivity reactions and fluid retention. |
| custirsen (OGX-011)/mitoxantrone | DRUG | All subjects began treatment with oral prednisone (5 mg twice daily, 10 mg/day) continued through completion of the final treatment cycle. Three IV administrations of OGX-011 (640 mg) were given as 2 hr infusions during the loading dose period (Days-9 to-1). Subjects were premedicated with either ibuprofen (400 mg) or acetaminophen (650 mg) 30 to 60 minutes prior to and every 4-6 hours for 24 hours following each of the three doses of OGX-011 during the loading dose period only. After the loading dose period, OGX-011 was given weekly on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was administered IV on Day 1 of each cycle at a planned dose of 12 mg/m² infused over 30 minutes. Patients could receive a maximum of 9 cycles of treatment. |
| custirsen (OGX-011)/docetaxel | DRUG | All subjects began treatment with oral prednisone (5 mg twice daily, 10 mg/day) continued through completion of the final treatment cycle. Three IV administrations of OGX-011 (640 mg) were given as 2 hr infusions during the loading dose period (Days-9 to -1). Subjects were premedicated with either ibuprofen (400 mg) or acetaminophen (650 mg) 30 to 60 minutes prior to and every 4-6 hours for 24 hours following each of the three doses of OGX-011 during the loading dose period only. After the loading dose period, OGX-011 was given weekly on Days 1, 8, and 15 of each 21 day cycle. Docetaxel was administered IV on Day 1 of each cycle at a planned dose of 75 mg/m² infused over 60 minutes. Patients could receive a maximum of 9 cycles of treatment. |
Inclusion Criteria * Age ≥ 18 years on the date of consent. * Histological or cytological diagnosis of adenocarcinoma of the prostate. * Metastatic disease on chest, abdominal, or pelvic CT and/or bone scan. * Systemic chemotherapy indicated due to progression while on or after androgen ablative th...