A Randomized, Open Label, Multicenter Study of Cabazitaxel Versus an Androgen Receptor (AR; targeted Agent (Abiraterone or Enzalutamide) in mCRPC Patients Previously Treated with Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent (CARD) - CARD

Sanofi-aventis0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Sanofi-aventis
入组人数: 15

研究概览入排标准研究者记录与标识符相似试验

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: 18 至 99（—）

入选标准

•1) Histologically or cytologically confirmed prostate adenocarcinoma.
•2) Metastatic disease.
•3) Effective castration with serum testosterone levels lower than 0.5 ng/mL.
•4) Progressive disease defined by at least one of the following:
•- Progression in measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria).
•- Appearance of 2 or more new bone lesions (Prostate Cancer Working Group 2 [PCWG2]).;- Rising PSA (PCWG2).;5) Having received prior docetaxel for at least 3 cycles (before or after an AR-targeted therapy).
•6) Having progressive disease (PD) while receiving AR-targeted therapy with abiraterone acetate or enzalutamide within 12 months of AR treatment initiation (*12 months).
•7) A PSA value of at least 2 ng/mL is required at study entry.
•8) Prior AR-targeted therapy (abiraterone acetate or enzalutamide) must be stopped at least 2 weeks before study treatment.
•9) Signed informed consent.

排除标准

•1) Prior chemotherapy other than docetaxel for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed more than 3 years ago.;2) Less than 28 days elapsed from prior treatment with chemotherapy, immunotherapy, radiotherapy, or surgery to the time of randomization.;3) Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of Grade >1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.0) at the time of randomization.;4) Eastern Cooperative Oncology Group performance status (ECOG PS) >2 (ECOG 2 must be related to prostate cancer, not to other comorbidities).;5) Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which treatment has been completed *5 years ago and from which the patient has been disease-free for *5 years.;6) Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.;7) Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.;8) Patients with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period and up to 6 months after the last administered dose. The definition of "effective method of contraception" will be based on the Investigator*s judgment.;9) Known allergies, hypersensitivity or intolerance to prednisone or excipients of abiraterone acetate, enzalutamide, docetaxel, or polysorbate 80.;10) Known history of mineralo-corticoid excess or deficiency.;11) History of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain arteriovenous malformation, brain metastases, or the use of concomitant medications that may lower the seizure threshold.;12) Unable to swallow a whole tablet or capsule.;13) Inadequate organ and bone marrow function as evidenced by:;- Hemoglobin <10.0 g/dL;;- Absolute neutrophil count <1.5 × 10^9/L;;- Platelet count <100 × 10^9/L;;- aspartate aminotransferase/serum glutamic oxaloacetic transaminase and/or alanine aminotransferase/serum glutamic pyruvic transaminase >1.5 × the upper limit of normal (ULN);;- Total bilirubin >1.0 × ULN;;- Potassium <3.5 mmol/L;;- Child-Pugh Class C;;14) Contraindications to the use of corticosteroid treatment.;15) Symptomatic peripheral neuropathy Grade >2 (NCI CTCAE v4.0).;16) Uncontrolled severe illness or medical condition including uncontrolled diabetes mellitus, history of cardiovascular disease (uncontrolled hypertension, arterial thrombotic events in the past 6 months, congestive heart failure, severe or unstable angina pectoris, recent myocardial infarction within the last 6 months, or uncontrolled cardiac arrhythmia).;17) Concomitant vaccination with yellow fever vaccine.

研究者

发起方

Sanofi-aventis

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