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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01084655 | Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer | PHASE1 | COMPLETED | 38 | — | — | Jul 1, 2010 | Mar 1, 2016 | Jul 30, 2019 | 1 | United States |
PSA response rates (PSA-30, PSA-50, and PSA-90) were defined as greater than or equal to (\>=) 30%, 50%, and 90% reductions, respectively, from baseline in PSA concentration.
Best PSA response was defined as the maximum PSA percent reduction from baseline at any time beyond Cycle 1.
| Arm | Type | Description |
|---|---|---|
| Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone | EXPERIMENTAL | Orteronel (TAK-700) 200 milligram (mg), tablets, orally, twice daily (BID) starting from Day 1 along with docetaxel 75 milligram per square meter (mg/m\^2), infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods. |
| Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone | EXPERIMENTAL | Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m\^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods. |
| Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone | EXPERIMENTAL | Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15 along with docetaxel 75 mg/m\^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT). |
| Name | Type | Description |
|---|---|---|
| TAK-700 | DRUG | TAK-700 with docetaxel and prednisone on a continuous schedule. |
| Docetaxel | DRUG | TAK-700 with docetaxel and prednisone on a continuous schedule. |
| Prednisone | DRUG | TAK-700 with docetaxel and prednisone on a continuous schedule. |
Inclusion Criteria: Each patient must meet all of the following inclusion criteria: * Voluntary written consent * Male patients 18 years or older * Estimated life expectancy of 6 months or more * Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma * Radiograph-documented...