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Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (DUALIDES)

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: NCT02344017
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : December 19, 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, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: ODM-204 Drug: Prednisone Phase 1 Phase 2

Detailed Description:
The safety profile of ODM-204 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-204 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM-204 will be evaluated after single and multiple dose administrations at different dose levels.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC): Open, Non-Randomised, Uncontrolled, Multicentre, Dose Escalation, First-in-man Study With a Dose Expansion
Study Start Date : February 2015
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: ODM-204 Phase I dose escalation
Dose escalation
Drug: ODM-204
co-administered with prednisone, orally daily

Drug: Prednisone
ODM-204 is co-administered with oral prednisone

Experimental: ODM-204 Phase II dose expansion Drug: ODM-204
co-administered with prednisone, orally daily

Drug: Prednisone
ODM-204 is co-administered with oral prednisone




Primary Outcome Measures :
  1. Safety and tolerability assessed by incidence of adverse events [ Time Frame: Until disease progression, an expected average of 6 months ]
  2. Safety and tolerability assessed by vitals signs and 12-lead ECG [ Time Frame: Until disease progression, an expected average of 6 months ]
  3. Safety and tolerability assessed by laboratory assessments [ Time Frame: Until disease progression, an expected average of 6 months ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile assessed by plasma peak concentration (Cmax) [ Time Frame: 0 - week 12 ]
  2. Pharmacokinetic profile assessed by area under the concentration-time curve (AUC) [ Time Frame: 0 - week 12 ]
  3. Pharmacokinetic profile assessed by time to reach peak concentration (tmax) [ Time Frame: 0 - week 12 ]
  4. Preliminary antitumour activity assessed by prostate specific antigen (PSA) response [ Time Frame: Until disease progression, an expected average of 6 months ]
  5. Preliminary antitumour activity assessed by response in soft and bone tissues [ Time Frame: Until disease progression, an expected average of 6 months ]
  6. Pharmacodynamic profile assessed by hormone and circulating tumour cell measurements [ Time Frame: 0 - week 12 ]


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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

Inclusion Criteria:

  • Written informed consent (IC) obtained.
  • 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:

  • History of pituitary or adrenal dysfunction.
  • Known brain metastases.
  • Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.
  • Uncontrolled hypertension
  • Clinically significant heart disease
  • Prolonged QTc interval

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): NCT02344017


Locations
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Finland
Helsinki University Central Hospital
Helsinki, Finland
France
Institut Gustave Roussy
Villejuif, France
Latvia
P. Stradins Clinical University Hospital
Riga, Latvia
United Kingdom
Velindre Cancer Centre
Cardiff, 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: NCT02344017    
Other Study ID Numbers: 3116001
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents