Progressive castration resistant prostate cancer (MedDRA: hormone-refractory prostate cancer) MedDRA version: 14.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ODM-201
Product Code: ODM-201
Pharmaceutical Form: Capsule
INN or Proposed INN: .
Current Sponsor code: ODM-201
Sponsors
Orion Corporation Orion Pharma
Eligibility
Sex/Gender
Male
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 the end-of study visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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-ofstudy 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. | — |
Countries
Czech Republic, Estonia, Finland, France, United Kingdom, United States
Contacts
Public ContactChirag Patel
ORION Clinical Services Ltd
Outcome results
None listed