Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT02344017
Last Updated: 2019-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
23 participants
INTERVENTIONAL
2015-02-28
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ODM-204 Phase I dose escalation
Dose escalation
ODM-204
co-administered with prednisone, orally daily
Prednisone
ODM-204 is co-administered with oral prednisone
ODM-204 Phase II dose expansion
ODM-204
co-administered with prednisone, orally daily
Prednisone
ODM-204 is co-administered with oral prednisone
Interventions
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ODM-204
co-administered with prednisone, orally daily
Prednisone
ODM-204 is co-administered with oral prednisone
Eligibility Criteria
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Inclusion Criteria
* Male aged ≥ 18 years.
* Histologically or cytologically confirmed adenocarcinoma of prostate.
* Ongoing GnRH agonist or antagonist therapy, or after bilateral orchiectomy.
* Progressive metastatic disease
* Adequate bone marrow, hepatic, and renal function
* Acceptable and regular bowel movements without any GI disorder or procedure which may interfere with absorption of study treatment
* Ability to swallow study treatments
Exclusion Criteria
* Known brain metastases.
* Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.
* Uncontrolled hypertension
* Clinically significant heart disease
* Prolonged QTc interval
18 Years
MALE
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Karim Fizazi
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Helsinki University Central Hospital
Helsinki, , Finland
Institut Gustave Roussy
Villejuif, , France
P. Stradins Clinical University Hospital
Riga, , Latvia
Velindre Cancer Centre
Cardiff, , United Kingdom
Countries
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Other Identifiers
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3116001
Identifier Type: -
Identifier Source: org_study_id