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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03436485
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : January 29, 2024
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Study Description
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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 Drug: Midazolam Phase 1 Phase 2

Detailed Description:
Safety and tolerability profile of ODM-208 will be explored
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 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 : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Midazolam

Arms and Interventions
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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
Experimental: ODM-208 Part 2 Drug drug interaction Drug: ODM-208
co-administered with glucocorticoid and fludrocortisone, orally daily

Drug: Midazolam
orally


Outcome Measures
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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


Eligibility Criteria
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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.
  • Part 1: Treatment with at least 1 line of chemotherapy or ineligibility for chemotherapy. Part 2: Treatment with at least 1 line of taxane-based chemotherapy in castration-sensitive prostate cancer (CSPC) or in CRPC.

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 significantly abnormal serum potassium or sodium level.
  • Active or unstable cardio/cerebro-vascular disease including thromboembolic events.
  • Prolonged QTcF interval.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Principal Investigator: Karim Fizazi Gustave Roussy, Cancer Campus, Grand Paris
More Information
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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT03436485    
Other Study ID Numbers: 3124001
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: January 29, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
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
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
 Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action