Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Orteronel · 2 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.
| Arm | Type | Description |
|---|---|---|
| Orteronel + prednisone | EXPERIMENTAL | - |
| Placebo + prednisone | PLACEBO_COMPARATOR | - |
| 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. |
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 in patients with metastatic castration-resistant prostate cancer. It has been evaluated in Phase 3 clinical trials in combination with prednisone. As of the available data, Orteronel remains investigational and is not approved by regulatory authorities.
Orteronel is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The company has conducted Phase 3 clinical trials evaluating Orteronel in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer.
Orteronel is in Phase 3 clinical development for prostate cancer. Two Phase 3 trials have been completed, both evaluating Orteronel plus prednisone in patients with metastatic castration-resistant prostate cancer. The drug is still investigational and has not been approved for any use.
Orteronel has been studied in two completed Phase 3 trials. NCT01193244 enrolled 1560 participants with chemotherapy-naive metastatic castration-resistant prostate cancer, and NCT01193257 enrolled 1099 participants with metastatic castration-resistant prostate cancer. Both trials were randomized, double-blind, and placebo-controlled, with a combined enrollment of 2659 participants.
Orteronel is a small molecule that targets the enzyme CYP17, which is involved in androgen production. By inhibiting this enzyme, Orteronel is designed to reduce androgen levels, potentially slowing the growth of prostate cancer. This mechanism was evaluated in Phase 3 trials in combination with prednisone for metastatic castration-resistant prostate cancer.
Orteronel is also known as TAK-700, a name used in some clinical and research contexts. It is being developed by Takeda Pharmaceutical Company Limited for the treatment of prostate cancer. The drug has been evaluated in Phase 3 trials for metastatic castration-resistant prostate cancer.