Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Orteronel
TAK-700 · 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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TAK-700 is an investigational small molecule being studied for the treatment of prostate cancer, specifically metastatic castration-resistant prostate cancer. It has been evaluated in combination with docetaxel and prednisone in men with this form of advanced prostate cancer. TAK-700 is not approved and remains in clinical development.
TAK-700 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor responsible for the clinical development of this small molecule oncology candidate.
TAK-700 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.
TAK-700 has been studied in one completed Phase 1 trial, NCT01084655, titled Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer. The trial enrolled 38 men in the United States and used a controlled design without randomization or double blinding.
TAK-700 is not approved and remains an investigational drug in clinical development. Its only recorded trial, a Phase 1 study in metastatic castration-resistant prostate cancer, has been completed. No regulatory approval has been granted for TAK-700 in any indication.
The completed Phase 1 trial of TAK-700, NCT01084655, enrolled 38 patients. Participants were men aged 18 years and older with metastatic castration-resistant prostate cancer, and the study was conducted in the United States.