Spots Global Cancer Trial Database for Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer.
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Trial Identification
Brief Title: Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer.
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel
Study ID: NCT01972217
Study Description
Brief Summary: This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo given in addition to abiraterone. Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg twice daily (bid) will be administered with the abiraterone in this study.
Detailed Description: This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and PK of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo-controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo in addition to abiraterone. Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg bid will be administered with the abiraterone in this study, but throughout this protocol the treatment will be referred to simply as abiraterone. For Part A of the study, 15 to 18 evaluable patients (Cohorts 1 and 2) are planned to be enrolled from approximately 4 sites in approximately 1 or 2 countries, and a further 12 patients may be recruited into a 3rd cohort if necessary. For Part B of the study, approximately 140 patients who have received prior chemotherapy containing docetaxel will be randomised from approximately 40 sites in North America and Europe. Patients who have been dosed in Part A of the study may not participate in Part B.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Research Site, San Diego, California, United States
Research Site, Lake Success, New York, United States
Research Site, Edegem, , Belgium
Research Site, Liège, , Belgium
Research Site, Wilrijk, , Belgium
Research Site, London, Ontario, Canada
Research Site, Greenfield Park, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Brno, , Czechia
Research Site, Brno, , Czechia
Research Site, Liberec, , Czechia
Research Site, Angers, , France
Research Site, Dijon, , France
Research Site, LYON cedex 08, , France
Research Site, Lecce, , Italy
Research Site, Mirano, , Italy
Research Site, Napoli, , Italy
Research Site, Parma, , Italy
Research Site, Pisa, , Italy
Research Site, Arnhem, , Netherlands
Research Site, Maastricht, , Netherlands
Research Site, Nijmegen, , Netherlands
Research Site, Gdańsk, , Poland
Research Site, Warszawa, , Poland
Research Site, Ivanovo, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, St. Petersburg, , Russian Federation
Research Site, Badalona, , Spain
Research Site, Córdoba, , Spain
Research Site, Gerona, , Spain
Research Site, L'Hospitalet de Llobregat, , Spain
Research Site, Madrid, , Spain
Research Site, Palma de Mallorca, , Spain
Research Site, Valencia, , Spain
Research Site, Cardiff, , United Kingdom
Research Site, Exeter, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Plymouth, , United Kingdom
Research Site, Torquay, , United Kingdom
Research Site, Westcliff-on-Sea, , United Kingdom
Contact Details
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