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

Phase 1

Conditions: METASTATIC CASTRATION-RESISTANT PROSTATE CANCER OR ESTROGEN RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED BREAST CANCER
MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864
MedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2018-002249-13-ES

Lead Sponsor: Orion Corporation Orion Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 256

Inclusion Criteria

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 CT or 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)metastases present)•serum total bilirubin/=3.0 g/dl•serum/plasma creatinine12Resolution of the acute toxic effects from prior cancer therapy or surgical procedures to the NCI CTCAE v4.03 Grade13Able to follow the study instructions, to comply with the replacement therapy dosing and regimen, and other study requirements
14Able to swallow tablets
15AR mutation positive cohorts
BC patients
1Signed written IC obtained
2Female 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 carcinoma
4.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 confirmation
6.Perf

Exclusion Criteria

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 checkpoin

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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