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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ODM-204
Prednisone
Sponsored by
Orion Corporation, Orion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Central Hospital
  • Institut Gustave Roussy
  • P. Stradins Clinical University Hospital
  • Velindre Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ODM-204 Phase I dose escalation

ODM-204 Phase II dose expansion

Arm Description

Dose escalation

Outcomes

Primary Outcome Measures

Safety and tolerability assessed by incidence of adverse events
Safety and tolerability assessed by vitals signs and 12-lead ECG
Safety and tolerability assessed by laboratory assessments

Secondary Outcome Measures

Pharmacokinetic profile assessed by plasma peak concentration (Cmax)
Pharmacokinetic profile assessed by area under the concentration-time curve (AUC)
Pharmacokinetic profile assessed by time to reach peak concentration (tmax)
Preliminary antitumour activity assessed by prostate specific antigen (PSA) response
Preliminary antitumour activity assessed by response in soft and bone tissues
Pharmacodynamic profile assessed by hormone and circulating tumour cell measurements

Full Information

First Posted
December 29, 2014
Last Updated
December 17, 2019
Sponsor
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02344017
Brief Title
Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer
Acronym
DUALIDES
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 Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orion Corporation, Orion Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ODM-204 Phase I dose escalation
Arm Type
Experimental
Arm Description
Dose escalation
Arm Title
ODM-204 Phase II dose expansion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ODM-204
Intervention Description
co-administered with prednisone, orally daily
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
ODM-204 is co-administered with oral prednisone
Primary Outcome Measure Information:
Title
Safety and tolerability assessed by incidence of adverse events
Time Frame
Until disease progression, an expected average of 6 months
Title
Safety and tolerability assessed by vitals signs and 12-lead ECG
Time Frame
Until disease progression, an expected average of 6 months
Title
Safety and tolerability assessed by laboratory assessments
Time Frame
Until disease progression, an expected average of 6 months
Secondary Outcome Measure Information:
Title
Pharmacokinetic profile assessed by plasma peak concentration (Cmax)
Time Frame
0 - week 12
Title
Pharmacokinetic profile assessed by area under the concentration-time curve (AUC)
Time Frame
0 - week 12
Title
Pharmacokinetic profile assessed by time to reach peak concentration (tmax)
Time Frame
0 - week 12
Title
Preliminary antitumour activity assessed by prostate specific antigen (PSA) response
Time Frame
Until disease progression, an expected average of 6 months
Title
Preliminary antitumour activity assessed by response in soft and bone tissues
Time Frame
Until disease progression, an expected average of 6 months
Title
Pharmacodynamic profile assessed by hormone and circulating tumour cell measurements
Time Frame
0 - week 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim Fizazi
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Facility Name
P. Stradins Clinical University Hospital
City
Riga
Country
Latvia
Facility Name
Velindre Cancer Centre
City
Cardiff
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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