JPRN-jRCT2011200005进行中（未招募）3 期
A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer
Kimura Akiko0 个研究点目标入组 575 人开始时间: 2020年10月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 575
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
- >= 18age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •Men with histologically or cytologically confirmed adenocarcinoma of the prostate
- •-Prior treatment with one, and only one, NHT (eg, abiraterone, apalutamide, darolutamide, or enzalutamide) for castration-sensitive locally advanced (T3 or T4) or metastatic Castration-sensitive prostate cancer (mCSPC), Non-metastatic Castration-resistant prostate cancer (M0 CRPC), or mCRPC
- •-Surgical or medical castration, with serum testosterone =< 50 ng/dL (=< 1.73 nmol/L) at screening
- •-Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment defined by at least one of the following: measurable visceral disease (eg, adrenal, kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic adenopathy (ie, adenopathy above the aortic bifurcation)
- •-Progressive disease (PD) at study entry as defined by specific criteria for prostate specific antigen (PSA) progression OR soft tissue disease progression in the opinion of the Investigator (Note: subjects with bone disease progression alone are not eligible)
- •-Age >= 18 years old or meeting country definition of adult, whichever is older, on the day of consent
- •-Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •-Recovery to baseline or =< Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator
- •-Adequate organ and marrow function based upon specific laboratory assessments obtained within 21 days prior to randomization
- •-Understanding and ability to comply with protocol requirements
排除标准
- •-Any prior nonhormonal therapy initiated for the treatment of mCRPC
- •-Receipt of abiraterone within 1 week; cyproterone within 10 days; or flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within 2 weeks before randomization
- •-Radiation therapy within 4 weeks (2 weeks for bone metastases) prior to randomization (subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible)
- •-Known brain metastases or cranial epidural disease unless adequately treated and clinically stable at least 4 weeks prior to randomization
- •-Symptomatic or impending spinal cord compression or cauda equina syndrome
- •-Concomitant anticoagulation with oral anticoagulants (some specific exceptions apply)
- •-Administration of a live, attenuated vaccine within 30 days prior to randomization
- •-Systematic treatment with, or any condition requiring, either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization
- •-Uncontrolled, significant intercurrent or recent illness
- •-Major surgery within 4 weeks prior to randomization
- •-Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram(ECG) within 21 days before randomization
- •-Inability or unwillingness to swallow pills or receive IV administration
- •-Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies
- •-Any other active malignancy at time of randomization or diagnosis of another malignancy within 2 years prior to randomization that requires active treatment (some exceptions apply such as locally curable cancers that have apparently been cured).
研究者
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