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Spots Global Cancer Trial Database for A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide

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Trial Identification

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

Interventions

Enzalutamide

Study Description

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).

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Sr. Medical Director

Affiliation: Astellas Pharma Global Development, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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