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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03878823
Other study ID # 3125001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date April 17, 2019
Est. completion date January 9, 2024

Study information

Verified date January 2024
Source Orion Corporation, Orion Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date January 9, 2024
Est. primary completion date January 9, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
ODM-209
co-administered with glucocorticoid and mineralocorticoid, orally daily

Locations

Country Name City State
Denmark Rigshospitalet, University Hospital of Copenhagen Copenhagen
Finland Helsinki University Central Hospital Helsinki
Finland Tampere University Hospital Tampere
France Institut Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Orion Corporation, Orion Pharma

Countries where clinical trial is conducted

Denmark,  Finland,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) Highest dose level at which under 33% of patients in a cohort experience DLT Within first 28 days of treatment
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