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临床试验/EUCTR2017-002534-23-GB
EUCTR2017-002534-23-GB进行中（未招募）1 期

SAFETY AND PHARMACOKINETICS OF ODM-208 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER - CYPIDES

Orion Corporation Orion Pharma0 个研究点目标入组 112 人开始时间: 2018年1月12日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
112
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 clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • •1. Written informed consent (IC) obtained.
  • •2. Males aged = 18 years.
  • •3. Life expectancy > 3 months.
  • •4. ECOG performance status 0-1.
  • •5. For Part 1/Phase 1: Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
  • •For Part 2/Phase 2: Histologically confirmed adenocarcinoma of the prostate without pure small cell features.
  • •6. Metastatic disease documented either by a positive bone scan, CT, PET/CT or MRI scan.
  • •7.Castration-resistant prostate cancer with serum testosterone < 50 ng/dl (< 0.5 ng/ml,< 1.7 nmol/l).
  • •8. Patients must maintain ongoing androgen deprivation therapy with a gonadotropinreleasing hormone (GnRH) analogue (agonist or antagonist), or have had bilateral orchiectomy.
  • •9. For Part 1/Phase 1: Treatment with at least 1 line of chemotherapy or ineligibility for chemotherapy. For Part 2/Phase 2: Treatment with at least 1 line of taxane-based chemotherapy in castration-sensitive prostate cancer (CSPC) or in CRPC.
  • •10. Treatment of at least 1 line of novel AR targeted hormonal therapy in CSPC or in CRPC for a minimum of 12 weeks (e.g. abiraterone, enzalutamide, darolutamide, apalutamide).
  • •11. [Obsolete inclusion criterion removed in Amendment 7.]
  • •12. Documented disease progression by one or more of the following criteria:
  • •- PSA progression defined by a minimum of 2 elevated PSA levels with an interval of at least 1 week between the measurements. The PSA value at the screening visit should be >=1 ng/ml (For Part2/Phase 2), >=2 ng/ml (for Part 1/Phase 1).
  • •- soft tissue disease progression as defined by RECIST 1.1 criteria.
  • •- bone disease progression as defined by PCWG3 criteria.
  • •13. Adequate marrow, liver and kidney function.
  • •- haemoglobin = 10 g/dl (in absence of blood transfusion within 7 days of value obtained)
  • •- absolute neutrophil count (ANC) = 1500/µl (1.5 x 10?/l)
  • •- platelet count = 100 000/µl (100 x 10?/l )
  • •- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 x upper limit of normal (ULN) (= 5.0 x ULN if liver metastases present)
  • •- total bilirubin = 1.5 x ULN (< 3 ULN if Gilbert's syndrome)
  • •- albumin = 3.0 g/dl
  • •- creatinine = 1.5 ULN or calculated creatinine clearance = 60 ml/min/1.73 m2 for patients with creatinine levels above normal limit
  • •17. For Part 2/Phase 2 only (added in Amendment 7): Patients with identified activating mutation in the LBD of AR in plasma ctDNA confirmed by the central testing
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 56
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 56

排除标准

  • •1. History of pituitary dysfunction.
  • •2. For Part 1/Phase 1: Known brain metastases or active leptomeningeal disease. For Part 2/Phase 2: Known brain metastases.
  • •3. Other concurrent malignancies, except adequately treated basal cell or squamous cell carcinoma of the skin. Patients who have undergone potentially curative therapy for a prior malignancy are eligible provided there is no evidence of disease for > 3 years (Part 2/Phase 2) or >=5 years (Part 1/Phase 1) and patient is deemed to be at low risk for recurrence.
  • •4. Active or uncontrolled autoimmune disease requiring concurrent corticosteroid therapy.
  • •5. Active infection or other medical condition that would make corticosteroid contraindicated.
  • •6. Use of aldosterone antagonist (e.g. spironolactone, eplerenone) and phenytoin within 4 weeks prior start of the study treatment.
  • •8. Prior radiotherapy, chemotherapy within the last 4 weeks (2 weeks for oral or weekly chemotherapy; 6 weeks for nitrosoureas and mitomycin C) prior to the start of the study treatment. Concurrent radiotherapy for palliation is allowed.
  • •9. Part 1/Phase 1: Use of enzalutamide within 4 weeks and abiraterone acetate within 2 weeks prior to the start of study treatment. Use of other
  • •anticancer therapy (excluding GnRH) within 4 weeks prior to the start of the study treatment. Use of immune checkpoint inhibitor within 12
  • •weeks prior to the start of the study treatment (amendment 4)
  • •Part 2/Phase 2: Use of enzalutamide and apalutamide within 3 weeks, use of darolutamide and abiraterone acetate within 2 weeks prior to the start of study treatment. Use of other anticancer therapy (excluding GnRH) within 4 weeks prior to the start of the study treatment. Use of immune checkpoint inhibitor within 12 weeks prior to the start of the study treatment.
  • •10. For Part 1/Phase 1 only: Known gastrointestinal (GI) disease or GI procedure that may interfere with absorption of study treatment.
  • •12. Hypotension: systolic BP < 110 mmHg, or uncontrolled hypertension: systolic = BP 160 mmHg or diastolic = BP 90 mmHg (for Part 2/Phase 2:
  • •95 mmHg), in 2 out of 3 recordings with optimized antihypertensive therapy.
  • •14. Active or unstable cardio/cerebro-vascular disease, including thromboembolic events. Examples include recent (within 6 months) myocardial infarction, coronary artery bypass graft or symptomatic cerebrovascular accident or congestive heart failure (New York Heart Association class III-IV) (for Part 1/Phase 1), III-IV (for Part 2/Phase 2).
  • •15. History or family history of long QTc syndrome. Repeatable prolongation (2 out of 3 recordings) of QTcF interval > 450 ms (for Part 1/Phase 1), > 470 ms (for Part 2/Phase 2), or any clinically significant abnormality in the centrally-read ECG.
  • •19. Known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  • •21. Participation in another interventional clinical trial with an investigational agent or any concurrent treatment with any investigational drug 4 weeks (immune checkpoint inhibitors 12 weeks) prior to the start of the study treatment.

研究者

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