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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: ODM-204; Drug: Prednisone

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University Central Hospital
• France
  • Villejuif, France
    • Institut Gustave Roussy
• Latvia
  • Riga, Latvia
    • P. Stradins Clinical University hospital
• United Kingdom
  • Cardiff, United Kingdom
    • Velindre Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability assessed by incidence of adverse events	Until disease progression, an expected average of 6 months
Safety and tolerability assessed by vitals signs and 12-lead ECG	Until disease progression, an expected average of 6 months
Safety and tolerability assessed by laboratory assessments	Until disease progression, an expected average of 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: December 29, 2014
• First Submitted That Met QC Criteria: January 16, 2015
• First Posted (Estimate): January 22, 2015

Study Record Updates

• Last Update Posted (Actual): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: 3116001