Uncontrolled, Open-label, Non-randomized Phase I Study to Investigate Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics of a Single Dose of BAY88-8223 in Japanese Patients With Castration-resistant Prostate Cancer and Bone Metastases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 19
- 主要终点
- Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples
研究概览
简要总结
This is an uncontrolled, open-label, non-randomized Phase I study to investigate safety, biodistribution, radiation dosimetry and pharmacokinetics of a single dose of BAY88-8223 in Japanese patients with castration-resistant prostate cancer and bone metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male ≥ 20 years of age
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Presents with at least 2 bone metastases, confirmed by scintigraphic imaging within the previous 4 weeks
- •Patients who has failed initial hormonal therapy using either an orchiectomy or a Gonadotropin releasing hormone (GnRH) agonist in combination with an antiandrogen must first progress through antiandrogen withdrawal prior to being eligible. The minimum timeframe to document failure of anti-androgen withdrawal will be four weeks
- •Progressive castration resistant metastatic disease
- •Castrate level of testosterone (<50 ng/dL), treatment to maintain castrate levels of testosterone must be continued
排除标准
- •Has received an investigational drug in the 4 weeks before or is scheduled to receiving one during or in the 8 weeks after study drug administration.
- •Has received chemo-, immuno-, or radiotherapy within the last 4 weeks prior to entry in the study, or has not recovered from acute adverse events as a result of such therapy
- •Has received prior hemibody external radiotherapy
- •Has a need for immediate external radiotherapy
- •Has received systemic radiotherapy with radium-223, strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last 24 weeks prior to administration of study drug
- •When receiving bisphosphonates, has changed the dose within 4 weeks before administration of study drug
研究组 & 干预措施
Radium-223 dichloride [50 kBq/kg]
干预措施: Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)
Radium-223 dichloride [100 kBq/kg]
干预措施: Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)
Radium-223 dichloride [expansion]
干预措施: Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)
结局指标
主要结局
Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples
时间窗: up to 72 hours
Number of participants with Critical toxicities
时间窗: Up to day 28
Critical toxicities (using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0) will be defined as the occurrence of one or more of the following drug-related toxicities: 1) ≥Grade 3 non-hematologic toxicity, 2) Grade 3 neutropenia with fever, 3) Grade 4 neutropenia that failed to recover to grade 2 or less after treatment with Granulocyte colony-stimulating factor (GCSF) within 2 weeks, 4) Grade 4 thrombocytopenia
Maximum drug concentration in blood after single dose administration (Cmax) of BAY88-8223 for blood samples
时间窗: up to 72 hours
次要结局
- Changes in prostate specific antigen (PSA)(baseline, up to 12 weeks)
- Overall Survival(Up to 36 months)