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

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344017
• Other study ID #: 3116001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2015
• Est. completion date: January 2019

Study information

• Verified date: December 2019
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• ODM-204
co-administered with prednisone, orally daily
• Prednisone
ODM-204 is co-administered with oral prednisone

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
France	Institut Gustave Roussy	Villejuif
Latvia	P. Stradins Clinical University Hospital	Riga
United Kingdom	Velindre Cancer Centre	Cardiff

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Countries where clinical trial is conducted

Finland,  France,  Latvia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability assessed by incidence of adverse events		Until disease progression, an expected average of 6 months
Primary	Safety and tolerability assessed by vitals signs and 12-lead ECG		Until disease progression, an expected average of 6 months
Primary	Safety and tolerability assessed by laboratory assessments		Until disease progression, an expected average of 6 months
Secondary	Pharmacokinetic profile assessed by plasma peak concentration (Cmax)		0 - week 12
Secondary	Pharmacokinetic profile assessed by area under the concentration-time curve (AUC)		0 - week 12
Secondary	Pharmacokinetic profile assessed by time to reach peak concentration (tmax)		0 - week 12
Secondary	Preliminary antitumour activity assessed by prostate specific antigen (PSA) response		Until disease progression, an expected average of 6 months
Secondary	Preliminary antitumour activity assessed by response in soft and bone tissues		Until disease progression, an expected average of 6 months
Secondary	Pharmacodynamic profile assessed by hormone and circulating tumour cell measurements		0 - week 12