JPRN-jRCT2080222485未知1 期
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: 2014年5月14日最近更新:
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •1)Patient has histologically or cytologically confirmed prostate adenocarcinoma
- •2)Patients who have not received androgen deprivation treatment (e.g., GnRH agonist, GnRH antagonist, steroidal antiandrogen, non-steroidal androgen) for prostate cancer.
- •3)Patients who have not undergone surgical castration
- •4)Serum testosterone at screening > 150 ng/dL
- •5)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •1)Patients who have received 5-alpha reductase inhibitors
- •2)Patients who have received chemotherapy for prostate cancer (including Estramustine)
- •3)Patients who have received 125I-brachytherapy radiation therapy
- •4)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.
研究者
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