Safety and Pharmacokinetics of ODM-209 (STESIDES)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03878823 |
Recruitment Status :
Completed
First Posted : March 18, 2019
Last Update Posted : February 1, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer Metastatic Advanced Breast Cancer Castration-resistant Prostate Cancer Metastatic Breast Cancer | Drug: ODM-209 | Phase 1 Phase 2 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 17, 2019 |
Actual Primary Completion Date : | January 9, 2024 |
Actual Study Completion Date : | January 9, 2024 |
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 |
- 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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878823
Denmark | |
Rigshospitalet, University Hospital of Copenhagen | |
Copenhagen, Denmark | |
Finland | |
Helsinki University Central Hospital | |
Helsinki, Finland | |
Tampere University Hospital | |
Tampere, Finland | |
France | |
Institut Gustave Roussy | |
Villejuif, France |
Study Director: | Jutta Hänninen | Orion Corporation, Orion Pharma |
Responsible Party: | Orion Corporation, Orion Pharma |
ClinicalTrials.gov Identifier: | NCT03878823 |
Other Study ID Numbers: |
3125001 |
First Posted: | March 18, 2019 Key Record Dates |
Last Update Posted: | February 1, 2024 |
Last Verified: | January 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
metastatic castration-resistant prostate cancer advanced hormone receptor positive breast cancer |
Breast Neoplasms Prostatic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |