- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03878823
Safety and Pharmacokinetics of ODM-209 (STESIDES)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ODM-209 Part 1 Dose escalation
|
co-administered with glucocorticoid and mineralocorticoid, orally daily
|
Experimental: ODM-209 Part 2 Dose expansion
|
co-administered with glucocorticoid and mineralocorticoid, orally daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD)
Time Frame: Within first 28 days of treatment
|
Highest dose level at which under 33% of patients in a cohort experience DLT
|
Within first 28 days of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jutta Hänninen, Orion Corporation, Orion Pharma
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3125001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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