Advanced Breast Cancer, Castration-resistant Prostate Cancer, Metastatic Breast Cancer, Prostate Cancer Metastatic
Conditions
Keywords
metastatic castration-resistant prostate cancer, advanced hormone receptor positive breast cancer
Brief summary
The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.
Detailed description
Part 1: 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 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.
Interventions
DRUGODM-209
co-administered with glucocorticoid and mineralocorticoid, orally daily
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
MAIN INCLUSION CRITERIA: * Written informed consent (IC) obtained. * Age ≥ 18 years. * ECOG performance status 0-1. * Adequate marrow, liver and kidney function. * Able to swallow study treatment. Main Prostate cancer specific inclusion criteria: * Histologically confirmed adenocarcinoma of the prostate. * Castration resistant prostate cancer with serum testosterone \< 50 ng/dl. * Metastatic disease. * Ongoing androgen deprivation therapy with GnRH analogue, or have had bilateral orchiectomy. * Have had treatment with at least one line of second generation androgen receptor targeting therapy and one line of chemotherapy. Main Breast cancer specific inclusion criteria: * Histologically confirmed breast carcinoma * ER positive, HER2-negative advanced breast cancer * Postmenopausal or pre/perimenopausal if amendable to be treated with GnRH agonist or antagonist. * Documented disease progression after treatment with at least 2 lines of systemic treatment for advanced breast cancer. Of these, at least one line must have been endocrine treatment in combination with a cdk4/6 inhibitor. MAIN
Exclusion criteria
* History of pituitary dysfunction. * Known brain metastases or active leptomeningeal disease. * Active infection or other medical condition that would make corticosteroids contraindicated. * Hypotension or uncontrolled hypertension. * Clinically significant cardiovascular disease, e.g. myocardial infarction, arterial thrombotic events, or pulmonary embolism in the past six months, unstable angina, or congestive heart failure (New York Heart Association \[NYHA\] class II-IV). * Prolonged QTcF interval. * Use of any investigational drug 4 weeks prior to the start of the study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose (MTD) | Within first 28 days of treatment | Highest dose level at which under 33% of patients in a cohort experience DLT |
Countries
Denmark, Finland, France
Outcome results
None listed