Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

810

Participants

Timeline

Start Date

April 16, 2019

Primary Completion Date

August 11, 2021

Study Completion Date

December 31, 2025

Conditions
Biliary Tract Neoplasms
Interventions
DRUG

Durvalumab

IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

DRUG

Placebo

IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Trial Locations (126)

333

Research Site, Taoyuan District

613

Research Site, Chiayi City

704

Research Site, Tainan City

1280

Research Site, Ciudad de Buenos Aires

1330

Research Site, Sofia

1407

Research Site, Sofia

1606

Research Site, Sofia

2000

Research Site, Rosario

4600

Research Site, San Salvador de Jujuy

6189

Research Site, Nice

8000

Research Site, Burgas

9010

Research Site, Varna

10050

Research Site, Taipei

10330

Research Site, Bangkok

10400

Research Site, Bangkok

11217

Research Site, Taipei

13620

Research Site, Seongnam-si

19111

Research Site, Philadelphia

20007

Research Site, Washington D.C.

20132

Research Site, Milan

21079

Research Site, Dijon

27514

Research Site, Chapel Hill

33000

Research Site, Si Sa Ket

33110

Research Site, Mersin

33604

Research Site, Pessac

33705

Research Site, St. Petersburg

33905

Research Site, Fort Myers

34030

Research Site, Istanbul

34295

Research Site, Montpellier

35100

Research Site, Izmir

37134

Research Site, Verona

37203

Research Site, Nashville

37404

Research Site, Chattanooga

40002

Research Site, Khon Kaen

40202

Research Site, Louisville

40705

Research Site, Taichung

48018

Research Site, Faenza

50134

Research Site, Florence

50200

Research Site, Muang

63110

Research Site, St Louis

66205

Research Site, Westwood

75571

Research Site, Paris

80131

Research Site, Napoli

82445

Research Site, Kaohsiung City

83301

Research Site, Kaohsiung City

86021

Research Site, Poitiers

90027

Research Site, Los Angeles

90110

Research Site, Hat Yai

92210

Research Site, Clichy

92868

Research Site, Orange

97213

Research Site, Portland

98109

Research Site, Seattle

100003

Research Site, Shenyang

100021

Research Site, Beijing

100142

Research Site, Beijing

110085

Research Site, New Delhi

115478

Research Site, Moscow

121467

Research Site, Moscow

122001

Research Site, Gūrgaon

125284

Research Site, Moscow

150001

Research Site, Hong Kong

150081

Research Site, Harbin

156005

Research Site, Kostroma

197022

Research Site, Saint Petersburg

197758

Research Site, Saint Petersburg

200032

Research Site, Shanghai

210002

Research Site, Nanjing

215004

Research Site, Suzhou

230001

Research Site, Hefei

230601

Research Site, Hefei

233004

Research Site, Bengbu

250014

Research Site, Jinan

310003

Research Site, Hangzhou

310009

Research Site, Hangzhou

330006

Research Site, Nanchang

400012

Research Site, Mumbai

400038

Research Site, Chongqing

450008

Research Site, Zhengzhou

510062

Research Site, Guangzhou

519000

Research Site, Zhuhai

528000

Research Site, Foshan

644033

Research Site, Omsk

656049

Research Site, Barnaul

700160

Research Site, Kolkata

710061

Research Site, Xi'an

4810218

Research Site, Temuco

7630370

Research Site, Santiago

01805

Research Site, Burlington

C1118AAT

Research Site, Buenos Aires

C1426ANZ

Research Site, Buenos Aires

C1012AAR

Research Site, CABA

C1019ABS

Research Site, CABA

071000

Research Site, Baoding

Unknown

Research Site, Shandong

Research Site, Hong Kong

Research Site, Kowloon

00000

Research Site, Hong Kong

00168

Research Site, Roma

104-0045

Research Site, Chūōku

227-8577

Research Site, Kashiwa

362-0806

Research Site, Kitaadachi-gun

181-8611

Research Site, Mitaka-shi

541-8567

Research Site, Osaka

565-0871

Research Site, Suita-shi

641-8510

Research Site, Wakayama

241-8515

Research Site, Yokohama

80-952

Research Site, Gdansk

93-513

Research Site, Lodz

10-228

Research Site, Olsztyn

60-780

Research Site, Poznan

02-106

Research Site, Warsaw

50-556

Research Site, Wroclaw

03080

Research Site, Seoul

03722

Research Site, Seoul

06351

Research Site, Seoul

06591

Research Site, Seoul

152-703

Research Site, Seoul

06100

Research Site, Ankara

BS2 8ED

Research Site, Bristol

CB2 0QQ

Research Site, Cambridge

NW3 2QG

Research Site, London

W12 0NN

Research Site, London

M20 4BX

Research Site, Manchester

OX3 7LE

Research Site, Oxford

RM7 0AG

Research Site, Romford

S10 2SJ

Research Site, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY