Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer

Prostate Cancer Clinical Trial

— ARAFOR  

Official title:

A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784757
• Other study ID #: 3104003
• Secondary ID: 2012-002279-32
• Status: Completed
• Phase: Phase 1
• Start date: March 2013
• Est. completion date: December 2020

Study information

• Verified date: March 2021
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent (IC) obtained.

• Histologically confirmed adenocarcinoma of prostate

• Progressive metastatic disease

• Ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy

• Adequate bone marrow, hepatic and renal function

• Able to swallow the ODM-201 whole as a capsule or tablet.

Exclusion Criteria:

• Previous chemotherapy for prostate cancer.

• Known metastases in the brain.

• History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.

• Known gastrointestinal condition that can significantly affect the absorption of the study treatment.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• ODM-201 Tablet A
Tablet A formulation of ODM-201
• ODM-201 Tablet B
Tablet B formulation of ODM-201
• ODM-201 capsule formulation
Capsule formulation of ODM-201

Locations

Country	Name	City	State
Latvia	P. Stradina Clinical University Hospital	Riga

Sponsors (2)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma	Endo Pharmaceuticals

Country where clinical trial is conducted

Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) of ODM-201	The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration calculated with linear trapezoidal rule.	0-48 hrs
Primary	Cmax of ODM-201	The plasma peak concentration.	0-48 hrs
Secondary	tmax of ODM-201	The time to reach peak concentration.	0-48 hrs
Secondary	Terminal elimination rate constant of ODM-201	The terminal elimination rate constant from log-linear portion of a concentration-time curve.	0-48 hrs
Secondary	Terminal elimination half-life of ODM-201	The terminal elimination half-life that will be calculated with the equation ln2/terminal elimination rate constant.	0-48 hrs