JPRN-jRCT2031220214招募中3 期
This study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival of study participants, when overall survival is defined as the time from randomization until the date of death due to any cause. - CAPItello-280
Hibi Kazushige0 个研究点目标入组 80 人开始时间: 2022年7月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
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 <= 130age old（—）
- 性别
- Male
入选标准
- •Histologically-confirmed prostate adenocarcinoma without neuroendocrine or small cell cancers
- •- Metastatic disease documented prior to randomisation by clear evidence of 1 bone lesion or more (defined as 1 lesion with positive uptake on bone scan) and/or 1 soft tissue lesion or more (measurable or non-measurable)
- •- Patient must have been previously treated with a next generation hormonal agent (NHA), ie, abiraterone, enzalutamide, apalutamide or darolutamide, for prostate cancer for at least 3 months and shown evidence of disease progression (radiological or via PSA assessment) while receiving the NHA
- •- Evidence of mCRPC with progression of disease despite androgen deprivation therapy (ADT) and after anti-androgen withdrawal if applicable
- •- Serum testosterone level 50 ng/dL or less
- •- Candidate for docetaxel and steroid therapy
- •- Ongoing ADT with LHRH agonist, LHRH antagonist, or bilateral orchiectomy
- •- Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1 and anticipated minimum life expectancy of 12 weeks
- •- Confirmation that archival formalin-fixed paraffin-embedded (FFPE) tumour tissue sample which meets the minimum pathology and sample requirements is available to send to the central laboratory
- •- Able and willing to swallow and retain oral medication
- •- Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
排除标准
- •- Radiotherapy with a wide field of radiation within 4 weeks before start of study treatment
- •- Major surgery (excl. placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, internal stents) within 4 weeks of start of study treatment
- •- Brain metastases,or spinal cord compression (unless spinal cord compression is asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment)
- •- Any of the following cardiac criteria:
- •i. Mean resting corrected QT interval (QTc) >470 msec from 3 consecutive ECGs
- •ii. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
- •iii. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age,or any concomitant medication known to prolong the QT interval
- •iv. Experience of any of the following procedures or conditions in the preceding 6months: coronary artery bypass graft, vascular stent, myocardial infarction, unstable angina pectoris, congestive heart failure NYHA Grade 2 or less.
- •v. Uncontrolled hypotension - systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg
- •vi. Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition scan if an echocardiogram cannot be performed or is inconclusive)
- •- Clinically significant abnormalities of glucose metabolism as defined by any of the following:
- •i. Patients with diabetes mellitus (DM) type 1 or DM type 2 requiring insulin treatment
- •ii. HbA1c 8.0% (63.9 mmol/mol) or more
- •- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- •i. Absolute neutrophil count < 1.5x 10^9/L
- •ii. Platelet count < 100x 10^9/L
- •iii. Haemoglobin < 9 g/dL (< 5.59 mmol/L)
- •iv. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5x upper limit of normal (ULN) if no demonstrable liver metastases or > 5x ULN in the presence of liver metastases. Elevated alkaline phosphatase (ALP) is not exclusionary if due to the presence of bone metastases and liver function is otherwise considered adequate in the investigator's judgement
- •v. Total bilirubin > 1.5x ULN (participants with confirmed Gilbert's syndrome may be included in the study with a higher value)
- •vi. Creatinine clearance < 50 mL/min per the Cockcroft and Gault formula without the need for chronic dialysis;
- •- As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant and active bleeding diseases), which, in the investigator's opinion, makes it undesirable for the patient to participate in the study or that would jeopardise compliance with the protocol.
- •- Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib
- •- Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contra-indicates the use of an investigation
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