Clinical Trials /

Safety and Pharmacokinetics of ODM-209

NCT03878823

Description:

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

Related Conditions:
  • Breast Carcinoma
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Safety and Pharmacokinetics of ODM-209
  • 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 IDs

  • ORG STUDY ID: 3125001
  • NCT ID: NCT03878823

Conditions

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

Interventions

DrugSynonymsArms
ODM-209ODM-209 Part 1 Dose escalation

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
ODM-209 Part 1 Dose escalationExperimental
  • ODM-209
ODM-209 Part 2 Dose expansionExperimental
  • ODM-209

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Orion Corporation, Orion Pharma

Trial Keywords

  • metastatic castration-resistant prostate cancer
  • advanced hormone reseptor positive breast cancer

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