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Safety and Pharmacokinetics of ODM-209 (STESIDES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03878823
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Advanced Breast Cancer Castration-resistant Prostate Cancer Metastatic Breast Cancer Drug: ODM-209 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878823


Contacts
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Contact: Orion Pharma Clinical Study Director +358 10 426 7792 clinicaltrials@orionpharma.com

Locations
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Denmark
Rigshospitalet, University Hospital of Copenhagen Recruiting
Copenhagen, Denmark
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland
Tampere University Hospital Recruiting
Tampere, Finland
France
Institut Gustave Roussy Recruiting
Villejuif, France
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Study Director: Jutta Hänninen Orion Corporation, Orion Pharma
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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT03878823    
Other Study ID Numbers: 3125001
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Orion Corporation, Orion Pharma:
metastatic castration-resistant prostate cancer
advanced hormone receptor positive breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases