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Status:

COMPLETED

Safety and Pharmacokinetics of ODM-209

Lead Sponsor:

Orion Corporation, Orion Pharma

Conditions:

Prostate Cancer Metastatic

Advanced Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

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 OD...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    April 17 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 9 2024

    Estimated Enrollment :

    38 Patients enrolled

    Trial Details

    Trial ID

    NCT03878823

    Start Date

    April 17 2019

    End Date

    January 9 2024

    Last Update

    February 1 2024

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Rigshospitalet, University Hospital of Copenhagen

    Copenhagen, Denmark

    2

    Helsinki University Central Hospital

    Helsinki, Finland

    3

    Tampere University Hospital

    Tampere, Finland

    4

    Institut Gustave Roussy

    Villejuif, France