Safety and Pharmacokinetics of ODM-209

NCT ID: NCT03878823

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-17
• Study Completion Date: 2024-01-09

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.

Conditions

Prostate Cancer Metastatic; Advanced Breast Cancer; Castration-resistant Prostate Cancer; Metastatic Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ODM-209 Part 1 Dose escalation

Group Type: EXPERIMENTAL

ODM-209

Intervention Type: DRUG

co-administered with glucocorticoid and mineralocorticoid, orally daily

ODM-209 Part 2 Dose expansion

Group Type: EXPERIMENTAL

ODM-209

Intervention Type: DRUG

co-administered with glucocorticoid and mineralocorticoid, orally daily

Interventions

ODM-209

co-administered with glucocorticoid and mineralocorticoid, orally daily

Intervention Type: DRUG

Eligibility Criteria

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.

• 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.

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jutta Hänninen

Role: STUDY_DIRECTOR

Orion Corporation, Orion Pharma

Locations

Rigshospitalet, University Hospital of Copenhagen

Copenhagen, , Denmark

Helsinki University Central Hospital

Helsinki, , Finland

Tampere University Hospital

Tampere, , Finland

Institut Gustave Roussy

Villejuif, , France

Countries

Denmark; Finland; France

Other Identifiers

3125001

Identifier Type: -

Identifier Source: org_study_id