NCT01605227已完成3 期
A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) Versus Prednisone in Metastatic Castration-resistant Prostate Cancer Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100
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
- Exelixis
- 入组人数
- 1,028
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histological or cytological diagnosis of castration resistant prostate cancer (serum testosterone less than 50 ng/dL).
- •Evidence of bone metastasis related to prostate cancer on bone scans.
- •Received prior docetaxel (minimum cumulative dose of 225 mg/m2) and either abiraterone or MDV3100 treatment and has evidence of prostate cancer progression on each agent independently.
- •Maintenance of LHRH agonist or antagonist unless treated with orchiectomy.
- •Recovered from toxicities related to any prior treatments, unless the toxicities are clinically non significant or easily manageable.
- •Adequate organ and marrow function.
- •Capable of understanding and complying with the protocol requirements and signed the informed consent form.
- •Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment.
排除标准
- •Prior treatment with cabozantinib.
- •Treatment with docetaxel, abiraterone, or MDV3100 in the last 2 weeks; or with any other type of cytotoxic or investigational anticancer agent in the last 2 weeks.
- •Radiation within 4 weeks (excluded if to mediastinum) or radionuclide treatment within 6 weeks of randomization.
- •Known brain metastases or cranial epidural disease.
- •Requires concomitant treatment, in therapeutic doses, with anticoagulants.
- •Requires chronic concomitant treatment of strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's Wort).
- •Uncontrolled, significant intercurrent illness including, but not limited to, cardiovascular disorders, gastrointestinal disorders, active infections, non-healing wounds, recent surgery.
- •Clinically significant hematemesis or hemoptysis, or other signs indicative of pulmonary hemorrhage in the last 3 months, or history of other significant bleeding in the past 6 months.
- •Cavitating pulmonary lesion(s) or a lesion invading or encasing a major blood vessel.
- •QTcF > 500 ms within 7 days of randomization.
- •Unable to swallow capsules or tablets.
- •Previously-identified allergy or hypersensitivity to components of the study treatment formulations.
- •Another diagnosis of malignancy requiring systemic treatment within 2 years of randomization.
研究组 & 干预措施
cabozantinib
Experimental
Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
干预措施: cabozantinib (Drug)
prednisone
Active Comparator
Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
干预措施: prednisone (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: OS was measured from the time of randomization until 614 events, approximately 24 months after study start
The primary analysis of OS is defined as the time from randomization to death due to any cause. Participants that had not died or were permanently lost to follow-up were censored at the last known date alive. Median OS was calculated using Kaplan-Meier estimates. Analysis for OS was performed after 614 events had occurred.
次要结局
- Bone Scan Response (BSR)(BSR was measured at the end of Week 12 as determined by the IRF)
研究者
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