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Brief Title: A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide
Official Title: A Multicenter, Single-arm, Open-label, Postmarketing Safety Study to Evaluate the Risk of Seizure Among Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated With Enzalutamide Who Are at Potential Increased Risk of Seizure
Study ID: NCT01977651
Brief Summary: The objective of this study was to evaluate the incidence of seizures and monitor the safety of enzalutamide treatment in participants with metastatic castration-resistant prostate cancer (mCRPC) known to have risk factor(s) for seizure.
Detailed Description: This was a multicenter, single-arm, open-label, postmarketing safety study to evaluate the risk of seizure among patients with mCRPC treated with enzalutamide who were at potential increased risk of seizure. Participants who met all inclusion and none of the exclusion criteria were enrolled into the study and participated in a 4-month treatment period, during which once daily dosing of enzalutamide (160 mg/day) occurred. At the end of the 4-month treatment period, participants who were assessed as deriving benefit from enzalutamide treatment were allowed to continue in the extension period where participants continued to receive enzalutamide until 1 of the following criteria was met: 1. The participant experienced bone disease progression per Prostate Cancer Working Group 2 (PCWG2) guidelines or soft tissue disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 2. The participant initiated treatment with another anticancer therapy or, in the opinion of the investigator, continued dosing would have led to undue risk to the patient 3. The participant met a discontinuation criterion 4. The sponsor terminated the study Participants who continued to receive clinical benefit from treatment with enzalutamide and did not meet any discontinuation criteria may have transitioned to an open label roll-over extension study upon approval of the study protocol at the institution where they were receiving treatment. Participants who did not continue in the extension period or who met a discontinuation criterion were discontinued from enzalutamide therapy and completed a follow-up visit 30 days from the last dose of enzalutamide or prior to the initiation of another anticancer therapy, whichever occurred first. For participants who continued on treatment after the 12-month extension period, data collection was limited to dosing information, concomitant medications, and all adverse events (AEs) including serious adverse events (SAEs).
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Site US10005, Anchorage, Alaska, United States
Site US10024, Detroit, Michigan, United States
Site US10026, Bronx, New York, United States
Site US10001, New York, New York, United States
Site US10014, New York, New York, United States
Site US10039, Syracuse, New York, United States
Site US10016, Durham, North Carolina, United States
Site US10008, Dallas, Texas, United States
Site US10025, Seattle, Washington, United States
Site AR54001, Berazategui, Buenos Aires, Argentina
Site AR54006, Ciudad Autonoma de BuenosAires, Buenos Aires, Argentina
Site AR54002, Buenos Aires, Caba, Argentina
Site AR54003, Cordoba, , Argentina
Site AR54004, Santa Fe, , Argentina
Site AR54005, Tucuman, , Argentina
Site AU61012, Kogarah, New South Wales, Australia
Site AU61005, Randwick, New South Wales, Australia
Site AU61011, Sydney, New South Wales, Australia
Site AU61001, Tweed Heads, New South Wales, Australia
Site AU61002, Nambour, Queensland, Australia
Site AU61007, Adelaide, South Australia, Australia
Site AU61004, Ballarat, Victoria, Australia
Site BE32004, Anderlecht, , Belgium
Site BE32001, Kortrijk, , Belgium
Site BE32003, Liege, , Belgium
Site CA15005, Abbotsford, British Columbia, Canada
Site CA15014, Halifax, Nova Scotia, Canada
Site CA15004, Brampton, Ontario, Canada
Site CA15010, Scarborough, Ontario, Canada
Site CA15001, Quebec City, Quebec, Canada
Site CL56001, Temuco, IX Region, Chile
Site CL56004, Santiago, , Chile
Site CL56002, Temuco, , Chile
Site CL56003, Vina del Mar, , Chile
Site CZ42004, Praha 2, , Czechia
Site CZ42002, Praha 6, , Czechia
Site FI35803, Helsinki, , Finland
Site FI35801, Oulu, , Finland
Site FI35802, Tampere, , Finland
Site FR33002, Lyon Cedex 03, , France
Site FR33004, Rouen Cedex, , France
Site FR33005, Suresnes, , France
Site DE49009, Nürtingen, Baden-Württemberg, Germany
Site DE49003, Berlin, , Germany
Site DE49001, Munster, , Germany
Site HU36002, Sopron, Gyor-Moson Sopron, Hungary
Site IL97202, Kfar Saba, HaMerkaz, Israel
Site IL97201, Be'er Ya'akov, , Israel
Site IL97203, Beer-Sheva, , Israel
Site IL97205, Haifa, , Israel
Site IL97204, Jerusalem, , Israel
Site IL97208, Nahariya, , Israel
Site IL97206, Petah-Tiqva, , Israel
Site IL97207, Ramat Gan, , Israel
Site IT39005, Meldola, Emilia-Romagna, Italy
Site IT39001, Cremona, Lombardia, Italy
Site IT39002, Arezzo, , Italy
Site IT39003, Roma, , Italy
Site KR82006, Seongnam-Si, Gyeonggi-do, Korea, Republic of
Site KR82007, Seoul, , Korea, Republic of
Site KR82003, Seoul, , Korea, Republic of
Site KR82001, Seoul, , Korea, Republic of
Site KR82004, Seoul, , Korea, Republic of
Site NZ64001, Hamilton, , New Zealand
Site SG65002, Singapore, , Singapore
Site ES34007, Hospitalet de Llobregat, Barcelona, Spain
Site ES34005, Sabadell, Barcelona, Spain
Site ES34001, Pamplona, Navarra, Spain
Site ES34003, Barcelona, , Spain
Site ES34004, Barcelona, , Spain
Site ES34006, Madrid, , Spain
Site SE46001, Goteborg, , Sweden
Site SE46002, Orebro, , Sweden
Site TW88601, Kaohsiung, , Taiwan
Site TW88603, Taipei City, , Taiwan
Site GB44002, Sutton, Surrey, United Kingdom
Name: Sr. Medical Director
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR