Safety and Pharmacokinetics of ODM-209

NCT03878823 | Completed Phase 1 DMC

• 1 other identifier: 3125001
• Study Type: interventional
• Target: 38
• Locations: 3 countries
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  Highest dose level at which under 33% of patients in a cohort experience DLT

  Within first 28 days of treatment

Study Arms (2)

ODM-209 Part 1 Dose escalation

EXPERIMENTAL

Drug: ODM-209

ODM-209 Part 2 Dose expansion

EXPERIMENTAL

Drug: ODM-209

Interventions

ODM-209 DRUG

co-administered with glucocorticoid and mineralocorticoid, orally daily

ODM-209 Part 1 Dose escalation; ODM-209 Part 2 Dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (4)

Rigshospitalet, University Hospital of Copenhagen

Copenhagen, Denmark

Location

Helsinki University Central Hospital

Helsinki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Institut Gustave Roussy

Villejuif, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jutta Hänninen

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 18, 2019
• Study Start: April 17, 2019
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

DK (1); FR (1); FI (2)