STESIDES: Safety and Pharmacokinetics of ODM-209
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ODM-209 Part 1 Dose escalation
|
Drug: ODM-209
co-administered with glucocorticoid and mineralocorticoid, orally daily
|
| Experimental: ODM-209 Part 2 Dose expansion
|
Drug: ODM-209
co-administered with glucocorticoid and mineralocorticoid, orally daily
|
Outcome Measures
Primary Outcome Measures
- Maximum tolerated dose (MTD) [Within first 28 days of treatment]
Highest dose level at which under 33% of patients in a cohort experience DLT
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rigshospitalet, University Hospital of Copenhagen | Copenhagen | Denmark | ||
| 2 | Helsinki University Central Hospital | Helsinki | Finland | ||
| 3 | Tampere University Hospital | Tampere | Finland | ||
| 4 | Institut Gustave Roussy | Villejuif | France |
Sponsors and Collaborators
- Orion Corporation, Orion Pharma
Investigators
- Study Director: Jutta Hänninen, Orion Corporation, Orion Pharma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3125001