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临床试验/EUCTR2018-002249-13-FI
EUCTR2018-002249-13-FI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: 2018年11月12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
  • •2 Male aged =18 years
  • •3 Patients with histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  • •4 Metastatic disease documented with a biopsy and/or imaging using CTor MRI
  • •5 CRPC with serum testosterone < 50 ng/dl (< 1.7 nmol/l)
  • •6 Have 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
  • •7 Patients must maintain ongoing androgen deprivation therapy with a gonadotropin releasing hormone analogue (either an agonist or an antagonist) or have had bilateral orchiectomy
  • •8 Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  • •9 Have had treatment with at least 1 line of chemotherapy for advanced disease or be ineligible for chemotherapy
  • •10 Have 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
  • •11 Adequate 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
  • •12 Resolution 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)
  • •13 Able to follow the study instructions, to comply with the replacement therapy dosing and regimen, and other study requirements
  • •14. Able to swallow tablets
  • •15. AR 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 confir

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)
  • •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 last dose of ODM-209
  • •24. Use of any investigational drug 4 weeks (immune checkpoint

研究者

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