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临床试验/EUCTR2018-002249-13-DK
EUCTR2018-002249-13-DK进行中（未招募）1 期

SAFETY AND PHARMACOKINETICS OF ODM-209 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER OR ESTROGEN RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED BREAST CANCER - STESIDES

Orion Corporation Orion Pharma0 个研究点目标入组 256 人开始时间: 2019年2月11日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
256
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
All

入选标准

  • •PC patients
  • •1Signed written IC obtained
  • •2Male aged =18 years
  • •3Patients with histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  • •4Metastatic disease documented with a biopsy and/or imaging using CTor MRI
  • •5CRPC with serum testosterone < 50 ng/dl (< 1.7 nmol/l)
  • •6Have documented disease progression by one or more of the following criteria
  • •a.PSA progression as defined by a minimum of 2 rising PSA levels with an interval of = 1 week between each assessment with serum PSA at the time of screening = 2 ng/ml b.Soft tissue disease progression as defined by the RECIST 1.1 criteria c.Bone disease progression as defined by the PCWG3 criteria
  • •7Patients must maintain ongoing androgen deprivation therapy with a gonadotropin releasing hormone analogue (either an agonist or an antagonist) or have had bilateral orchiectomy
  • •8Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  • •9Have had treatment with at least 1 line of chemotherapy for advanced disease or be ineligible for chemotherapy
  • •10Have had treatment with targeted endocrine therapy (defined as a second-generation antiandrogen therapy with e.g. abiraterone, enzalutamide, apalutamide, darolutamide) for castration-sensitive prostate cancer (CSPC) and/or for CRPC
  • •11Adequate marrow, liver, and kidney function defined as follows
  • •hemoglobin =10 g/dl (in absence of blood transfusion within 7 days of value obtained)•absolute neutrophil count (ANC) =1500/µl (1.5 x
  • •109/l)•platelet count =100 000/µl (100 x 109/l)•serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3 x the upper limit of normal (ULN) (=5.0 x ULN if liver metastases present)•serum total bilirubin =1.5 x ULN (< 3 ULN if Gilbert's syndrome)•serum albumin =3.0 g/dl•serum/plasma creatinine =1.5 ULN•serum potassium and sodium within the institutional normal reference range limits
  • •12Resolution of the acute toxic effects from prior cancer therapy or surgical procedures to the NCI CTCAE v4.03 Grade =1 (except for alopecia, nail changes, and grade 2 peripheral neuropathy)
  • •13Able to follow the study instructions, to comply with the replacement therapy dosing and regimen, and other study requirements
  • •14Able to swallow tablets
  • •14Able to swallow tablets
  • •15AR mutation positive cohorts
  • •BC patients
  • •1 Signed written IC obtained
  • •2 Female aged =18 years who are either
  • •Postmenopausal, as defined by at least one of the following criteria: age = 60 years;age < 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females documented bilateral oophorectomy
  • •medically confirmed ovarian failure•Pre/peri-menopausal (i.e not meeting the criteria for being postmenopausal) if amenable to be treated
  • •with the GnRH agonist or antagonist. Patients must have commenced treatment with GnRH agonist or antagonist at least 4 weeks prior to start of study treatment
  • •3 Patients with histologically confirmed breast carcinoma4. ER-positive breast cancer (defined as >1% cancer cell nuclei stain positively) based on a biopsy
  • •5 HER2-negative breast cancer (defined as immunohistochemistry [IHC] status 0 or 1+ or negative in situ hybridization [ISH] test) based on the most recent biopsy. If HER2 IHC is 2+ a negative ISH test is required. HER2 3+ (IHC) do not need ISH con

排除标准

  • •Prostate cancer patients
  • •1. History of pituitary dysfunction
  • •2. Known brain metastases or active leptomeningeal disease
  • •3. Concurrent other invasive malignancy; patients who have undergone potentially curative therapy for a prior invasive malignancy are eligible provided there is no evidence of disease for = 5 years after the diagnosis
  • •4. Active or uncontrolled autoimmune disease requiring concurrent corticosteroid therapy
  • •5. Active infection or other medical condition that would make corticosteroids contraindicated
  • •6. Use of aldosterone antagonist or phenytoin within 4 weeks prior to start of study treatment
  • •7. Patients with an unstable dose of thyroid hormone replacement therapy within 6 months prior to the start of the study treatment
  • •8. Chemotherapy (or CDK4/6 inhibitor therapy in Breast cancer patients)
  • •within 3 weeks prior to the start of the study treatment
  • •9. Radiotherapy within 2 weeks prior to start of the study treatment
  • •10. 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 agonists/antagonists) within 3 weeks prior to the start of the study treatment. Use of immune checkpoint inhibitor within 12 weeks prior to start of the study treatment.
  • •11. Use of any investigational second-generation antiandrogen therapy (prostate cancer) in phase 2
  • •12. GI disease that may interfere with absorption of the study treatment
  • •13. Poorly controlled diabetes or other diseases that may interfere with the study treatment
  • •14. History of seizure or any condition that may predispose to seizure
  • •15. Clinically significant cardiovascular disease, e.g. myocardial infarction, arterial thrombotic events, or pulmonary embolism in the past 6 months, unstable angina, or congestive heart failure (NYHA class II-IV)
  • •16. Recent symptomatic cerebrovascular accident within one month e.g. TIA, stroke or cerebral hemorrhage
  • •17. Hypotension: supine systolic BP < 110 mmHg, or uncontrolled hypertension: supine systolic BP =160 mmHg or diastolic BP =100 mmHg, in 2 out of 3 recordings with optimized antihypertensive therapy
  • •18. History or family history of the long QTc syndrome. Repeatable prolongation of the QTcF interval > 450 ms or any clinically significant abnormality in the ECG
  • •19. Sexually active subject, who does not agree to use condoms during the study and until 3 months after the last dose of ODM-209 (prostate cancer)
  • •20. Major surgery within 4 weeks before the start of the study treatment
  • •21. Severe or uncontrolled concurrent medical condition or psychiatric illness
  • •22. Known history of HIV infection
  • •23. Acute or chronic hepatitis B or hepatitis C infection
  • •24. Use of any investigational drug 4 weeks (immune checkpoint inhibitors 12 weeks) prior to the start of the study treatment
  • •For breast cancer only:
  • •10. Administration of endocrine therapy other than GnRH therapy for breast cancer in premenopausal women within 2 weeks (except for fulvestrant within 4 weeks), or ovarian ablation therapy within 8 weeks prior to the start of the study treatment
  • •22. Subject is pregnant or breast-feeding. Subject with childbearing potential (i.e. menstruating, or less than 12 months from the last menstruation) must have a negative pregnancy test
  • •23. Subject of childbearing potential who does not agree to use highly effective contraception (e.g. hormonal contraception, intrauterine device [IUD] or surgical sterilization during the study and until 3 months after the la

研究者

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