NL-OMON53373招募中2 期
A randomized phase II trial of docetaxel or cabazitaxel with or without darolutamide in men with metastatic castration-resistant prostate cancer. - Docetaxel or cabazitaxel with or without darolutamide in mCRPC
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 245
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. Age >= 18 years;
- •2. A confirmed diagnosis of progressive mCRPC (progression according to
- •Prostate cancer Working Group (PCWG) 3 criteria), with an indication for
- •docetaxel or cabazitaxel. Progression defined as >= 1 of the following 3
- •a. Radiographic disease progression in soft tissue per RECIST v1.1
- •b. Radiographic disease progression in bone defined by the appearance of >= 2
- •new bone lesions on bone scan.
- •c. PSA progression defined as >= 2 sequential rises in PSA obtained >= 1 week
- •apart with a minimal starting value of >= 1 ng/mL. A PSA value >= 2 ng/mL is
- •required at study entry.
- •3. Patients should have had disease progression previously on at least one ARSi
- •(abiraterone, apalutamide, darolutamide or enzalutamide). ARSi administration
- •is allowed both in the mCNPC and in the mCRPC setting. Co-administration of
- •docetaxel in mCNPC (triplet-therapy) is allowed.
- •4. WHO performance <= 2 (see appendix A)
- •5. Able and willing to sign the Informed Consent Form prior to screening
- •evaluations
- •6. Adequate haematological, renal and liver function and chemistry, defined as:
- •a. Hemoglobin >= 6.0 mmol/L
- •b. Platelets >= 100 x 109/L
- •c. ALT/AST <= 3x ULN and <= 5x ULN in case of liver metastases
- •d. Creatinine clearance >= 50 ml/min
- •e. Serum testosterone <= 1.7 nmol/L
排除标准
- •1. Impossibility or unwillingness to take oral drugs
- •2. Hypersensitivity to taxanes
- •3. Known serious illness or medical unstable conditions that could interfere
- •with this study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or
- •herpes zoster, organ transplants, kidney failure, serious liver disease (e.g.
- •severe cirrhosis), cardiac and respiratory diseases)
- •4. Symptomatic peripheral neuropathy CTCAE grade >=2
- •5. Docetaxel-rechallenge.
研究者
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