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

PHASE4CompletedINTERVENTIONAL
Enrollment

424

Participants

Timeline

Start Date

September 25, 2013

Primary Completion Date

February 1, 2016

Study Completion Date

January 11, 2019

Conditions
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Interventions
DRUG

Enzalutamide

Participants received 4 capsules (40 mg each) of enzalutamide orally once a day, for a total daily dose of 160 mg. Treatment was given with or without food and as close as possible to the same time each day.

Trial Locations (76)

1070

Site BE32004, Anderlecht

2031

Site AU61005, Randwick

2109

Site AU61011, Sydney

2217

Site AU61012, Kogarah

2485

Site AU61001, Tweed Heads

3204

Site NZ64001, Hamilton

3350

Site AU61004, Ballarat

4000

Site AR54005, San Miguel de Tucumán

4560

Site AU61002, Nambour

5000

Site AR54003, Córdoba

5042

Site AU61007, Adelaide

8500

Site BE32001, Kortrijk

9400

Site HU36002, Sopron

10048

Site TW88603, Taipei

10065

Site US10001, New York

Site US10014, New York

10461

Site US10026, The Bronx

12000

Site CZ42004, Prague

12200

Site DE49003, Berlin

13210

Site US10039, Syracuse

16000

Site CZ42002, Prague

21000

Site IL97208, Nahariya

26100

Site IT39001, Cremona

27710

Site US10016, Durham

28050

Site ES34006, Madrid

31008

Site ES34001, Pamplona

31096

Site IL97205, Haifa

33520

Site FI35802, Tampere

41345

Site SE46001, Gothenburg

44281

Site IL97202, Kfar Saba

47014

Site IT39005, Meldola

48149

Site DE49001, Münster

48202

Site US10024, Detroit

49100

Site IL97206, Petah Tikva

52100

Site IT39002, Arezzo

52621

Site IL97207, Ramat Gan

69437

Site FR33002, Lyon

70300

Site IL97201, Be’er Ya‘aqov

72622

Site DE49009, Nürtingen

75231

Site US10008, Dallas

76031

Site FR33004, Rouen

81362

Site TW88601, Kaohsiung City

84101

Site IL97203, Beersheba

90220

Site FI35801, Oulu

91120

Site IL97204, Jerusalem

92151

Site FR33005, Suresnes

98109

Site US10025, Seattle

99503

Site US10005, Anchorage

119228

Site SG65002, Singapore

2540364

Site CL56003, Viña del Mar

4781156

Site CL56002, Temuco

4810469

Site CL56001, Temuco

8420383

Site CL56004, Santiago

B1880BBF

Site AR54001, Berazategui

C1426ANZ

Site AR54006, Ciudad Autonoma de BuenosAires

C1120AAT

Site AR54002, Buenos Aires

S3000FFU

Site AR54004, Santa Fe

B-4000

Site BE32003, Liège

V2S 3N5

Site CA15005, Abbotsford

B3H 2Y9

Site CA15014, Halifax

L6T 4S5

Site CA15004, Brampton

M1S 4V5

Site CA15010, Scarborough Village

G1R3S1

Site CA15001, Québec

00290

Site FI35803, Helsinki

00144

Site IT39003, Roma

013620

Site KR82006, Seongnam-si

03080

Site KR82007, Seoul

135-710

Site KR82003, Seoul

135-720

Site KR82001, Seoul

137-701

Site KR82004, Seoul

08908

Site ES34007, L'Hospitalet de Llobregat

08208

Site ES34005, Sabadell

08025

Site ES34003, Barcelona

08035

Site ES34004, Barcelona

701 85

Site SE46002, Örebro

SM2 5PT

Site GB44002, Sutton

All Listed Sponsors
collaborator

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

INDUSTRY

lead

Astellas Pharma Global Development, Inc.

INDUSTRY

NCT01977651 - A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide | Biotech Hunter | Biotech Hunter