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Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer (CYPIDES)

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: NCT03436485
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Brief Summary:
The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Drug: ODM-208 Phase 1 Phase 2

Detailed Description:
Safety and tolerability profile of ODM-208 will be explored

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: ODM-208 Part 1 Dose escalation Drug: ODM-208
co-administered with glucocorticoid and fludrocortisone, orally daily

Experimental: ODM-208 Part 2 Dose expansion Drug: ODM-208
co-administered with glucocorticoid and fludrocortisone, 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:   Male
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Written informed consent (IC) obtained.
  • Male aged ≥ 18 years.
  • 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 antagonist, or have had bilateral orchiectomy.
  • Received at least one prior line of novel hormonal androgen receptor (AR) targeted therapy (e.g. abiraterone, enzalutamide).
  • ECOG performance status 0-1.
  • Adequate marrow, liver and kidney function.
  • Able to swallow study treatment.

Main Exclusion Criteria:

  • History of pituitary or adrenal dysfunction.
  • Known brain metastases or active leptomeningeal disease.
  • Active infection or other medical condition that would make corticosteroid contraindicated.
  • Poorly controlled diabetes.
  • Hypotension or uncontrolled hypertension.
  • Clinically significally abnormal serum potassium or sodium level.
  • Active or unstable cardio/cerebro-vascular disease including throboembolic events.
  • Prolonged QTcF interval (> 450 ms).

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): NCT03436485


Contacts
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Contact: Virpi Mononen, Clinical Study Manager +358 10 4261 virpi.mononen@orionpharma.com

Locations
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Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland
France
Institut Gustave Roussy Recruiting
Villejuif, France
United Kingdom
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Principal Investigator: Karim Fizazi Gustave Roussy, Cancer Campus, Grand Paris

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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT03436485     History of Changes
Other Study ID Numbers: 3124001
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases