| General information |
| Database: | DB00989 |
| Objective: | Orteronel (TAK700) is an investigational, nonsteroidal, oral, inhibitor of androgen synthesis with greater specificity for 17, 20lyase than for 17¦Áhydroxylase. they investigated orteronel without steroids in patients with nonmetastatic castrationresistant prostate cancer (nmCRPC; M0). |
| Authors: | Hussain M, et al |
| Title: | Phase II study of singleagent orteronel (TAK700) in patients with nonmetastatic castrationresistant prostate cancer and rising prostatespecific antigen. |
| Journal: | Clin Cancer Res. |
| Year: | 2014 |
| PMID: | 24965748 |
| Trial Design |
| Clinical Trial Id: | NCT01046916 |
| Agent: | orteronel
|
| Target: | 17 alphahydroxylaseC17, 20lyase
|
| Cancer Type: | prostate cancer |
| Cancer Subtype: | castrationresistant prostate cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase II study |
| Key Patients Feature: | Patients with nmCRPC and rising prostatespecific antigen (PSA) |
| Biomarker: | prostatespecific antigen |
| Biomark Analysis: | Singleagent orteronel produced marked and durable declines in PSA in patients with nmCRPC |
| Control Group Info: | single arm |
| Treatment Info: | pts received orteronel 300 mg twice daily until PSA progression, metastases, or unacceptable toxicity. |
| Primary End Point: | percentage of patients achieving PSA less than and equal to 0.2 ng/mL (undetectable levels) at 3 months. |
| Secondary End Point: | safety, PSA response, time to metastases, and correlated endpoints. |
| Patients Number: | 39 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 14.8 months (95% CI, 11.1-24.7). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Commonly reported treatmentemergent AEs included fatigue (64%) and gastrointestinal events, particularly diarrhea (38%) and nausea (33%). Twentytwo patients (56%) reported grade more than and equal to 3 AEs, of whom 2 had grade 4 AEs (1 each with pulmonary embolism and bladder cancer, both considered unrelated to orteronel treatment). Serious AEs were reported in 10 patients (26%). There were no onstudy deaths. AEs led to study discontinuation in 12 patients (31%) and included hypertension (patients with prior history of hypertension that worsened), dyspnea, and fatigue (each n = 2; 5%). |
| Conclusions: | Singleagent orteronel produced marked and durable declines in PSA in patients with nmCRPC. Orteronel has moderate but manageable toxicities and its chronic administration without steroids appears feasible. |