Safety and Pharmacokinetics of ODM-209

Metastatic Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878823
• Other study ID #: 3125001
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms
• Castration-resistant Prostate Cancer
• Metastatic Breast Cancer
• Prostate Cancer Metastatic
• Prostatic Neoplasms

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