A Phase 1, Randomized, Open-Label Study of TAK-385, an Oral Gonadotropin-Releasing Hormone (GnRH) Antagonist in Japanese Patients With Androgen Deprivation Treatment-Naive Nonmetastatic Prostate Cancer

TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 43 人开始时间: 待定

试验速览

暂无简介。

•Patient has histologically or cytologically confirmed prostate adenocarcinoma
•Patients who have not received androgen deprivation treatment (e.g., GnRH agonist, GnRH antagonist, steroidal antiandrogen, non-steroidal androgen) for prostate cancer.
•Patients who have not undergone surgical castration
•Serum testosterone at screening > 150 ng/dL
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

•Patients who have received 5-alpha reductase inhibitors
•Patients who have received chemotherapy for prostate cancer (including Estramustine)
•Patients who have received 125I-brachytherapy radiation therapy
•Diagnosis or treatment for another systemic malignancy within 2 years before the first dose. Patients who diagnosed with another malignancy and any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type will not be excluded if they have undergone complete resection.

DLT, adverse events, clinical laboratory tests, vital signs, and 12-lead ECGs Up to 48 weeks

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发起方

TAKEDA PHARMACEUTICAL COMPANY LTD.