Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-700 · 1 trial · 1 indication
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...
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TAK-700 is an investigational small molecule being studied for the treatment of prostate cancer, specifically in men with metastatic castration-resistant prostate cancer. It is being evaluated in combination with docetaxel and prednisone. As of the available data, TAK-700 is in Phase 1 clinical development and is not yet approved.
TAK-700 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in prostate cancer. TAK-700 is an investigational agent and has not received regulatory approval.
TAK-700 is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the drug in combination with docetaxel and prednisone in men with metastatic castration-resistant prostate cancer. The drug remains investigational and is not approved for any use.
TAK-700 has one completed clinical trial, NCT01084655, which was a Phase 1 study of TAK-700 in combination with docetaxel and prednisone in men with metastatic castration-resistant prostate cancer. The trial enrolled 38 participants in the United States and was a controlled, non-randomized, open-label study.
TAK-700 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for prostate cancer. A Phase 1 trial has been completed, but the drug has not yet progressed to later-stage trials or received regulatory approval for any indication.