Safety and Pharmacokinetics of ODM-209 (STESIDES)
Primary Purpose
Prostate Cancer Metastatic, Advanced Breast Cancer, Castration-resistant Prostate Cancer
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ODM-209
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer Metastatic focused on measuring metastatic castration-resistant prostate cancer, advanced hormone receptor positive breast cancer
Eligibility 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.
Sites / Locations
- Rigshospitalet, University Hospital of Copenhagen
- Helsinki University Central Hospital
- Tampere University Hospital
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ODM-209 Part 1 Dose escalation
ODM-209 Part 2 Dose expansion
Arm Description
Outcomes
Primary Outcome Measures
Maximum tolerated dose (MTD)
Highest dose level at which under 33% of patients in a cohort experience DLT
Secondary Outcome Measures
Full Information
NCT ID
NCT03878823
First Posted
March 15, 2019
Last Updated
December 21, 2022
Sponsor
Orion Corporation, Orion Pharma
1. Study Identification
Unique Protocol Identification Number
NCT03878823
Brief Title
Safety and Pharmacokinetics of ODM-209
Acronym
STESIDES
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orion Corporation, Orion Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Metastatic, Advanced Breast Cancer, Castration-resistant Prostate Cancer, Metastatic Breast Cancer
Keywords
metastatic castration-resistant prostate cancer, advanced hormone receptor positive breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ODM-209 Part 1 Dose escalation
Arm Type
Experimental
Arm Title
ODM-209 Part 2 Dose expansion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ODM-209
Intervention Description
co-administered with glucocorticoid and mineralocorticoid, orally daily
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD)
Description
Highest dose level at which under 33% of patients in a cohort experience DLT
Time Frame
Within first 28 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jutta Hänninen
Organizational Affiliation
Orion Corporation, Orion Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Rigshospitalet, University Hospital of Copenhagen
City
Copenhagen
Country
Denmark
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
12. IPD Sharing Statement
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Safety and Pharmacokinetics of ODM-209
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