Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments

PHASE3CompletedINTERVENTIONAL
Enrollment

266

Participants

Timeline

Start Date

February 6, 2015

Primary Completion Date

October 10, 2018

Study Completion Date

July 19, 2022

Conditions
Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity
Interventions
DRUG

OLAPARIB

300 mg olaparib tablets taken orally twice daily. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria.

DRUG

Single agent chemotherapy

Treatment of relapsed disease with single agent chemotherapy based on physician's choice of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria

Trial Locations (94)

1088

Research Site, Budapest

1115

Research Site, Budapest

1122

Research Site, Budapest

3000

Research Site, Leuven

3526

Research Site, Miskolc

4032

Research Site, Debrecen

5000

Research Site, Córdoba

6760

Research Site, México

9000

Research Site, Ghent

9024

Research Site, Győr

10408

Research Site, Goyang-si

11501

Research Site, Mineola

12208

Research Site, Albany

14004

Research Site, Córdoba

17007

Research Site, Girona

18014

Research Site, Granada

18101

Research Site, Afula

19001

Research Site, Abington

20132

Research Site, Milan

20133

Research Site, Milan

20141

Research Site, Milan

21204

Research Site, Towson

27599

Research Site, Chapel Hill

28040

Research Site, Madrid

28050

Research Site, Madrid

30905

Research Site, Fort Gordon

31096

Research Site, Haifa

35233

Research Site, Birmingham

36604

Research Site, Mobile

37232

Research Site, Nashville

37920

Research Site, Knoxville

43210

Research Site, Columbus

47014

Research Site, Meldola

48201

Research Site, Detroit

52621

Research Site, Ramat Gan

Research Site, Tel Litwinsky

53226

Research Site, Milwaukee

58100

Research Site, Holon

68000

Research Site, Oaxaca City

70300

Research Site, Ẕerifin

70433

Research Site, Covington

76022

Research Site, Bedford

77030

Research Site, Houston

80045

Research Site, Aurora

80120

Research Site, Littleton

80131

Research Site, Napoli

91120

Research Site, Jerusalem

94118

Research Site, San Francisco

95817

Research Site, Sacramento

97477

Research Site, Springfield

98158

Research Site, Messina

4941492

Research Site, Petah Tikva

6423906

Research Site, Tel Aviv

7661041

Research Site, Rehovot

9103102

Research Site, Jerusalem

06106

Research Site, Hartford

B1884BBF

Research Site, Berazategui

C1280AEB

Research Site, CABA

C1180AAX

Research Site, Ciudad de Buenos Aires

B1897GPD

Research Site, La Plata

T4000IAK

Research Site, San Miguel de Tucumán

98700-000

Research Site, Ijuí

99010 260

Research Site, Passo Fundo

90035-003

Research Site, Porto Alegre

90610-000

Research Site, Porto Alegre

22793-080

Research Site, Rio de Janeiro

15090-000

Research Site, São José do Rio Preto

01246-000

Research Site, São Paulo

01317-000

Research Site, São Paulo

M4N 3M5

Research Site, Toronto

M5G 1X6

Research Site, Toronto

H2L 4M1

Research Site, Montreal

500 05

Research Site, Hradec Králové

708 52

Research Site, Ostrava-Poruba

128 08

Research Site, Prague

762 75

Research Site, Zlín

00144

Research Site, Roma

00168

Research Site, Roma

07760

Research Site, México

80-219

Research Site, Gdansk

72-003

Research Site, Grzepnica

93-513

Research Site, Lodz

20-090

Research Site, Lublin

10-561

Research Site, Olsztyn

60-569

Research Site, Poznan

02-781

Research Site, Warsaw

03080

Research Site, Seoul

06273

Research Site, Seoul

06351

Research Site, Seoul

138-736

Research Site, Seoul

139-706

Research Site, Seoul

08035

Research Site, Barcelona

08036

Research Site, Barcelona

08907

Research Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Myriad Genetic Laboratories, Inc.

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

AstraZeneca

INDUSTRY