NCT01810770已完成3 期
A Single-arm, International, Prospective, Interventional, Open-label, Multicenter Study of Radium-223 Dichloride in the Treatment of Patients With Castration-Resistant Prostate Cancer (CRPC) With Bone Metastasis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 243
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability
研究概览
简要总结
To evaluate the safety and efficacy (Overall survival [OS]) of multiple doses of Ra-223 dichloride in an Asian population of subjects with CRPC metastatic to the bone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Patients diagnosed with progressive bone predominant metastatic Castration-Resistant Prostate Cancer (CRPC) /Hormone Refractory Prostate Cancer (HRPC) with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)
- •Known hormone refractory disease
- •No intention to use cytotoxic chemotherapy within the next 6 months
- •Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with external bean radiation therapy (EBRT) for bone pain within previous 12 weeks
- •Age >/= 18 years
- •Race is Asian
- •Eastern Co-operative Oncology Group (ECOG) Performance Status (PS): 0-2
- •Life expectancy >/= 6 months
- •Adequate bone marrow, liver and renal function as assessed by the Laboratory required by protocol
排除标准
- •Treatment with an investigational drug within previous 4 weeks prior to screening, or planned during the treatment or follow-up periods
- •Eligible for docetaxel treatment, i.e. subjects who are fit enough, willing and who are located where treatment with docetaxel is available
- •Treatment with cytotoxic chemotherapy within previous 4 weeks prior to screening, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks prior to screening (however ongoing neuropathy is permitted)
- •Prior hemibody external radiotherapy is excluded. Subjects who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets.
- •Received systemic therapy radionuclides (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
- •Blood transfusion or erythropoetin stimulating agents within the previous 4 weeks prior to screening
- •Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
- •Visceral metastases as assessed by abdominal/pelvic computed tomography (CT) or other imaging modality
- •Presence of brain metastases
- •Lymphadenopathy exceeding 3 cm in short-axis diameter
- •Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
- •Imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Subjects with history of spinal cord compression should have completely recovered.
- •Received local practice implant therapy containing lodine-125 or Palladium-103 for the primary lesion of prostate cancer within the 6 months prior to screening.
- •Any other serious illness or medical condition
研究组 & 干预措施
Radium-223 dichloride
Experimental
干预措施: Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability
时间窗: Up to 36 months
Number of participants with laboratory changes
时间窗: Up to 36 months
Number of participants with changes in vital signs
时间窗: Up to 36 months
Number of participants with changes in electrocardiogram (ECG)
时间窗: Up to 36 months
Overall Survival (OS)
时间窗: Up to 36 months
OS is defined as the time from date of first study drug treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
次要结局
- Changes in total Alkaline Phosphate (ALP) in serum(Up to 36 months)
- Number of participants with total-ALP normalization(Up to 36 months)
- Time to total ALP progression(Up to 36 months)
- Changes in prostate specific antigen (PSA) in serum(Up to 36 months)
- Time to PSA progression(Up to 36 months)
- Time to first skeletal related event (SRE)(Up to 36 months)
- SRE free survival(Up to 36 months)
- Time to occurrence of first use of radio-isotopes to relieve skeletal symptoms(Up to 36 months)
- Time to occurrence of first start of any other anti-cancer treatment(Up to 36 months)
- Time to occurrence of first deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)(Up to 36 months)
- Quality of life (QoL)(Up to 36 months)
- Time to pain progression(Up to 36 months)
研究者
相似试验
已完成
2 期
Study Evaluating SRA-333 in Mild to Moderate Alzheimer's Disease (AD)Alzheimer's DiseaseNCT00151333Wyeth is now a wholly owned subsidiary of Pfizer16
已完成
2 期
Standard Dose Versus High Dose and Versus Extended Standard Dose Radium-223 Dichloride in Castration-resistant Prostate Cancer Metastatic to the BoneProstatic NeoplasmsNCT02023697Bayer391
已完成
3 期
A Study of the Effectiveness and Safety of Prolonged-release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder.Attention Deficit Disorder With HyperactivityNCT00246220Janssen Pharmaceutica N.V., Belgium402
已完成
1 期
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic VolunteersOverweightObeseNCT02431442Rhythm Pharmaceuticals, Inc.57
已完成
2 期
A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With LupusLupus Erythematosus, SystemicLupusNCT00657189MedImmune LLC87