Safety and Pharmacokinetics of ODM-209 (STESIDES)

January 31, 2024 updated by: Orion Corporation, Orion Pharma

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

The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet, University Hospital of Copenhagen
  • Finland
      • Helsinki, Finland
        • Helsinki University Central Hospital
      • Tampere, Finland
        • Tampere University Hospital
  • France
      • Villejuif, France
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within first 28 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Study Director: Jutta Hänninen, Orion Corporation, Orion Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2019

Primary Completion (Actual)

January 9, 2024

Study Completion (Actual)

January 9, 2024

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3125001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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