Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TAK-700
Orteronel · 3 trials · 1 indication
Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.
rPFS was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause, whichever occurred first. Radiographic disease progression was evaluated by computerized tomography (CT) scan or magnetic resonance imaging (MRI) and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for soft tissue disease and Prostate Cancer Working Group (PCWG2) guidelines for bone disease. Participants who did not reach the endpoint were censored at their last assessment.
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 |
|---|---|---|
| Orteronel + prednisone | EXPERIMENTAL | - |
| Placebo + prednisone | PLACEBO_COMPARATOR | - |
| 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 |
|---|---|---|
| Orteronel | DRUG | Orteronel tablets |
| Prednisone | DRUG | Prednisone tablets |
| Orteronel Placebo | DRUG | Orteronel placebo-matching tablets |
| Placebo | DRUG | Placebo will be administered orally twice a day continuously throughout the study. Additionally, all patients will receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and a testosterone concentration of \<50 ng/dL. |
| 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. |
Inclusion Criteria: Each participant must meet all of the following inclusion criteria: * Voluntary written consent * Male 18 years or older * Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma * Radiograph-documented metastatic disease * Progressive disease * Prior sur...
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Orteronel is an investigational small molecule being studied for the treatment of prostate cancer, specifically metastatic castration-resistant prostate cancer. It has been evaluated in Phase 3 clinical trials in combination with prednisone in adult male patients. Orteronel is not approved for any indication and remains in clinical development.
Orteronel targets CYP17A1, an enzyme involved in androgen biosynthesis. It acts as an inhibitor of CYP17A1. By inhibiting this target, Orteronel is designed to reduce androgen production, which is relevant in prostate cancer. The molecular target is CYP17A1 and the target class is inhibitor.
Orteronel is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical development program for Orteronel in prostate cancer.
Orteronel is in Phase 3 clinical development. It is an investigational agent and has not been approved by the FDA or any regulatory authority. The Phase 3 program includes completed trials in metastatic castration-resistant prostate cancer.
Orteronel has been studied in two completed Phase 3 trials: NCT01193257, which enrolled 1099 participants with metastatic castration-resistant prostate cancer, and NCT01193244, which enrolled 1560 chemotherapy-naive participants with the same condition. Both trials evaluated Orteronel plus prednisone and were randomized, double-blind, and placebo-controlled.