METASTATIC CASTRATION-RESISTANT PROSTATE CANCER OR ESTROGEN RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED BREAST CANCER MedDRA version: 21.1 Level: LLT Classification code 10076506 Term: Castration-resistant prostate cancer System Organ Class: 100000004864 MedDRA version: 21.1 Level: LLT Classification code 10072737 Term: Advanced breast cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: ODM-209
Product Code: ODM-209
Pharmaceutical Form: Tablet
INN or Proposed INN: ODM-209
Other descriptive name: ODM-209
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Orion Corporation Orion Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
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 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 inhi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1: Primary objectives are - to evaluate the safety and tolerability of ODM-209; - to define the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ODM-209, if feasible; - to define the recommended dose of ODM-209 for prostate cancer and breast cancer patients and replacement therapy for Part 2 of the study. Part 2: - to further evaluate the safety and tolerability of ODM-209; - to evaluate the preliminary anticancer activity of ODM-209.;Secondary Objective: Part 1: - to characterise the pharmacokinetics (PK) of ODM-209 and its major metabolite ORM-38045 after single and repeated administrations; - to evaluate the dosing schedule of ODM-209. Part 2: - to evaluate the recommended dose of ODM-209 for further clinical studies.;Primary end point(s): - Safety: (serious) adverse events, vital signs including blood pressure, heart rate, body temperature and orthostatic test, 12-lead ECGs, physical exams, laboratory assessments: hematology, chemistry, urinalysis. - Efficacy assessments: Serum total PSA (only PC patients), soft tissue response by CT or MRI scan, bone scan (only PC patients), ECOG performance score, bone mineral density;Timepoint(s) of evaluation of this end point: - Safety: Determined at several time-points (continuously/every visit) - Efficacy assessments: Serum total PSA (every 4 weeks for 24 weeks; every 12 weeks thereafter), soft tissue response by CT or MRI scan (every 8 weeks for 24 weeks; every 12 weeks thereafter), bone scan (every 8 weeks for 24 weeks; every 12 weeks thereafter), ECOG performance score at each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Pharmacokinetic assessments: Part 1: Multiple blood samples for PK; additional single samples; Part 2 single samples - Plasma samples for protein binding; Metabolite screening: Multiple blood samples; urine collection - Pharmacodynamic assessments: Testosterone level or estradiol and estrone level and other steroid hormones;Timepoint(s) of evaluation of this end point: - Pharmacokinetic assessments: Part 1: Multiple blood samples for PK on study days 1 and 8; additional single samples on days 15 and 29 and week 16; Part 2 single samples on Day 1 and 15 and at week 16 - Plasma samples for protein binding at 2 time points on Day 8; Metabolite screening: Multiple blood samples on study days 1 and 8, and a single sample on Day29; urine collection on study days 1 and 8 - Pharmacodynamic assessments: Testosterone level or estradiol and estrone level and other steroid hormones: Multiple blood samples on study days 1 and 8. PD patients single samples on day 29, wk 16, wk 24, and every 12 weeks thereafter | — |
Countries
Denmark, Finland, Italy, Spain
Contacts
Public ContactJutta Hänninen
Orion Corporation Orion Pharma
Outcome results
None listed