SAFETY AND TOLERABILITY OF ODM-201 IN PATIENTS WITH PROSTATE CANCER: EXTENSION STUDY TO STUDY 3104001
- Conditions
- Progressive castration resistant prostate cancer (MedDRA: hormone-refractory prostate cancer)MedDRA version: 14.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022803-24-CZ
- Lead Sponsor
- Orion Corporation Orion Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 130
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;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<br>the end-of-study visit.
- Secondary Outcome Measures
Name Time Method 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. <br>ECOG performance status at baseline and then every 3 months.<br>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