SAFETY AND TOLERABILITY OF ODM-201 IN PATIENTS WITH PROSTATE CANCER: EXTENSION STUDY TO STUDY 3104001

• Register: EUCTR
• Last refreshed on: 8 February 2016
• Main ID: EUCTR2010-022803-24-FI
• Date of registration: 15/12/2011
• Prospective Registration: Yes
• Primary sponsor: Orion Corporation Orion Pharma
• Public title: SAFETY AND TOLERABILITY OF ODM-201 IN PATIENTS WITH PROSTATE CANCER: EXTENSION STUDY TO STUDY 3104001
• Scientific title: SAFETY AND TOLERABILITY OF ODM-201 IN PATIENTS WITH CASTRATE RESISTANT PROSTATE CANCER: OPEN, NON-RANDOMISED, UNCONTROLLED, MULTICENTRE, EXTENSION STUDY TO STUDY 3104001 - Arades-Ext Phase II
• Date of first enrolment: 06/02/2012
• Target sample size: 130
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022803-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Czech Republic, Estonia, Finland, France, United Kingdom, United States

Contacts

• Name: Virpi Mononen
• Affiliation: Orion Corporation Orion Pharma

• Name: Virpi Mononen
• Affiliation: Orion Corporation Orion Pharma

Key inclusion & exclusion criteria

Inclusion criteria:
1.Written informed consent (IC) obtained.
2.Patients who successfully completed 12 weeks of treatment according to study protocol 3104001, without any serious drug-related AEs or DLT.
3.Patient is expected to benefit from participation in the study in the opinion of the investigator.
4.Patients with any response or stable disease in study 3104001 at week 12. 5.Sexually active patients must agree to use condoms as an effective barrier method during the study treatment and for 3 months after the end of the treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion criteria:
1.New serious concurrent medical condition or psychiatric illness.
2.Any condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures. 3.The patient is not able to swallow the study treatment capsules.



Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Progressive castration resistant prostate cancer (MedDRA: hormone-refractory prostate cancer)
MedDRA version: 16.1 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Product Name: ODM-201
Product Code: ODM-201
Pharmaceutical Form: Capsule
INN or Proposed INN: .
Current Sponsor code: ODM-201
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Safety & tolerability evaluation at baseline (week 12 of study 3104001), then monthly for the first 6 months and then in 3-month intervals and at
the end-of-study visit.

Main Objective: The primary objective of this extension study is to gain more information about the long-term safety and tolerability of ODM-201.

Secondary Objective: Antitumour activity of ODM-201 will be evaluated by PSA response, changes in soft tissue and bone lesions, Eastern Cooperative Oncology Group (ECOG) performance status, and by the time on treatment.

Primary end point(s): To evaluate safety and tolerability of ODM-201 by assessing the adverse events using the NCI CTCAE version 4.03.

Secondary Outcome(s)

Secondary end point(s): Evaluation of efficacy by using assessing of PSA response, ECOG performance status, soft tissues changes and bone lesions.

Timepoint(s) of evaluation of this end point: PSA is evaluated at baseline (week 12 of study 3104001), then monthly for the first 6 months and then in 3-month intervals and at the end-of study visit.
ECOG performance status at baseline and then every 3 months.
Soft tissues changes and bone lesions are evaluated at baseline and then every 3 months, except for patients with no bone metastases or bone pain at baseline, the bone evalauation will be performed every 6 months

Secondary ID(s)

2010-022803-24-GB

3104002

Source(s) of Monetary Support

Orion Corporation Orion Pharma