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

A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

Sponsors

Lead Sponsor: AstraZeneca

Source AstraZeneca
Brief Summary

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

Detailed Description

A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers.

Overall Status Recruiting
Start Date April 16, 2019
Completion Date June 30, 2022
Primary Completion Date June 30, 2022
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Overall survival 40 months
Secondary Outcome
Measure Time Frame
PFS according to RECIST 1.1 using investigator assessment 40 months
ORR according to RECIST 1.1 using investigator assessment 40 months
DoR according to RECIST 1.1 using investigator assessment 40 months
EORTC QLQ-C30 and EORTC QLQ-BIL21 40 months
PFS, ORR, DoR, and DCR according to RECIST 1.1 using Investigator assessments and OS by PD-L1 expression 40 months
Serum concentration of durvalumab (peak and trough concentration) 40 months
Tiered results of ADAs for durvalumab 40 months
Enrollment 757
Condition
Intervention

Intervention Type: Drug

Intervention Name: Durvalumab

Description: 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.

Arm Group Label: Treatment Arm

Intervention Type: Drug

Intervention Name: Placebo

Description: 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.

Arm Group Label: Placebo Arm

Eligibility

Criteria:

Inclusion

1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.

2. Patients with preciously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.

3. Patient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.

4. WHO/ECOG PS of 0 or 1

Exclusion

1. History of another primary malignancy

2. Brain metastases or spinal cord compression

3. Uncontrolled intercurrent illness

4. Major surgical procedure within 28 days prior to the first dose of IP.

5. Prior locoregional therapy such as radioembolization

Gender: All

Minimum Age: 18 Years

Maximum Age: 130 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Gordon Cohen Study Director AstraZeneca
Overall Contact

Last Name: AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: [email protected]

Location
Facility: Status:
Research Site | Los Angeles, California, 90027, United States Recruiting
Research Site | Orange, California, 92868, United States Recruiting
Research Site | San Francisco, California, 94115, United States Recruiting
Research Site | Washington, District of Columbia, 20007, United States Recruiting
Research Site | Fort Myers, Florida, 33905, United States Recruiting
Research Site | Saint Petersburg, Florida, 33705, United States Recruiting
Research Site | Westwood, Kansas, 66205, United States Recruiting
Research Site | Louisville, Kentucky, 40202, United States Recruiting
Research Site | New Orleans, Louisiana, 70121, United States Not yet recruiting
Research Site | Burlington, Massachusetts, 01805, United States Recruiting
Research Site | Saint Louis, Missouri, 63110, United States Recruiting
Research Site | Chapel Hill, North Carolina, 27514, United States Recruiting
Research Site | Portland, Oregon, 97213, United States Recruiting
Research Site | Philadelphia, Pennsylvania, 19111, United States Recruiting
Research Site | Chattanooga, Tennessee, 37404, United States Recruiting
Research Site | Nashville, Tennessee, 37203, United States Recruiting
Research Site | Round Rock, Texas, 78665, United States Not yet recruiting
Research Site | Temple, Texas, 76508, United States Not yet recruiting
Research Site | Seattle, Washington, 98109, United States Recruiting
Research Site | Buenos Aires, 1280, Argentina Suspended
Research Site | Buenos Aires, C1118AAT, Argentina Recruiting
Research Site | Buenos Aires, C1426ANZ, Argentina Recruiting
Research Site | Caba, C1012AAR, Argentina Recruiting
Research Site | Caba, C1019ABS, Argentina Recruiting
Research Site | Cordoba, 5001, Argentina Withdrawn
Research Site | Rosario, 2000, Argentina Recruiting
Research Site | San Salvador de Jujuy, 4600, Argentina Recruiting
Research Site | Burgas, 8000, Bulgaria Recruiting
Research Site | Pleven, 5800, Bulgaria Recruiting
Research Site | Sofia, 1330, Bulgaria Recruiting
Research Site | Sofia, 1407, Bulgaria Not yet recruiting
Research Site | Sofia, 1606, Bulgaria Recruiting
Research Site | Sofia, Bulgaria Withdrawn
Research Site | Varna, 9010, Bulgaria Recruiting
Research Site | Puerto Montt, 5480000, Chile Not yet recruiting
Research Site | Santiago, 7630370, Chile Recruiting
Research Site | Santiago, 8330008, Chile Not yet recruiting
Research Site | Santiago, 8380455, Chile Withdrawn
Research Site | Santiago, 8380456, Chile Not yet recruiting
Research Site | Temuco, 4810218, Chile Recruiting
Research Site | Viña del Mar, 2540488, Chile Recruiting
Research Site | Baoding, 071000, China Not yet recruiting
Research Site | Beijing, 100142, China Not yet recruiting
Research Site | Bengbu, 233060, China Not yet recruiting
Research Site | ChongQing, 400038, China Not yet recruiting
Research Site | Foshan, 528000, China Not yet recruiting
Research Site | Guangzhou, 510062, China Not yet recruiting
Research Site | Hangzhou, 310003, China Not yet recruiting
Research Site | Hangzhou, 310009, China Not yet recruiting
Research Site | Harbin, 150081, China Not yet recruiting
Research Site | Hefei, 230001, China Not yet recruiting
Research Site | Nanchang, 330006, China Not yet recruiting
Research Site | Nanjing, 210002, China Not yet recruiting
Research Site | Shanghai, 200032, China Not yet recruiting
Research Site | Shenyang, 100003, China Not yet recruiting
Research Site | Xian, 710061, China Not yet recruiting
Research Site | Zhuhai, 519000, China Not yet recruiting
Research Site | Clichy, 92210, France Recruiting
Research Site | Dijon Cedex, 21079, France Recruiting
Research Site | Montpellier CEDEX 5, 34295, France Recruiting
Research Site | Nice, 6189, France Recruiting
Research Site | PARIS Cedex 12, 75571, France Recruiting
Research Site | Pessac, 33604, France Recruiting
Research Site | Poitiers, 86021, France Recruiting
Research Site | Hong Kong, 150001, Hong Kong Recruiting
Research Site | Hong Kong, Hong Kong Recruiting
Research Site | HongKong, 00000, Hong Kong Recruiting
Research Site | Kowloon, Hong Kong Recruiting
Research Site | Bangalore, 560068, India Not yet recruiting
Research Site | Bengaluru, 560076, India Not yet recruiting
Research Site | Gurgaon, 122001, India Not yet recruiting
Research Site | Kolkata, 700160, India Not yet recruiting
Research Site | Mumbai, 400012, India Not yet recruiting
Research Site | New Delhi, 110063, India Not yet recruiting
Research Site | New Delhi, 110076, India Not yet recruiting
Research Site | New Delhi, 110085, India Not yet recruiting
Research Site | Faenza, 48018, Italy Recruiting
Research Site | Firenze, 50134, Italy Recruiting
Research Site | Milano, 20132, Italy Recruiting
Research Site | Milano, 20162, Italy Not yet recruiting
Research Site | Napoli, 80131, Italy Recruiting
Research Site | Padova, 35128, Italy Not yet recruiting
Research Site | Roma, 00168, Italy Recruiting
Research Site | San Giovanni Rotondo, 71013, Italy Not yet recruiting
Research Site | Verona, 37134, Italy Recruiting
Research Site | Chuo-ku, 104-0045, Japan Recruiting
Research Site | Kashiwa, 227-8577, Japan Recruiting
Research Site | Kitaadachi-gun, 362-0806, Japan Recruiting
Research Site | Mitaka-shi, 181-8611, Japan Recruiting
Research Site | Osaka-shi, 541-8567, Japan Recruiting
Research Site | Suita-shi, 565-0871, Japan Recruiting
Research Site | Wakayama-shi, 641-8510, Japan Recruiting
Research Site | Yokohama-shi, 241-8515, Japan Recruiting
Research Site | Seongnam-si, 13620, Korea, Republic of Recruiting
Research Site | Seoul, 03080, Korea, Republic of Recruiting
Research Site | Seoul, 03722, Korea, Republic of Recruiting
Research Site | Seoul, 06351, Korea, Republic of Recruiting
Research Site | Seoul, 06591, Korea, Republic of Recruiting
Research Site | Seoul, 152-703, Korea, Republic of Recruiting
Research Site | Gdańsk, 80-214, Poland Recruiting
Research Site | Kościerzyna, 83-400, Poland Suspended
Research Site | Olsztyn, 10-228, Poland Recruiting
Research Site | Poznan, 60-780, Poland Recruiting
Research Site | Warszawa, 02-106, Poland Recruiting
Research Site | Wrocław, 50-556, Poland Recruiting
Research Site | Łódź, 93-509, Poland Recruiting
Research Site | Barnaul, 656049, Russian Federation Not yet recruiting
Research Site | Kostroma, 156005, Russian Federation Not yet recruiting
Research Site | Moscow, 115478, Russian Federation Recruiting
Research Site | Moscow, 121467, Russian Federation Not yet recruiting
Research Site | Moscow, 125284, Russian Federation Not yet recruiting
Research Site | Omsk, 644033, Russian Federation Not yet recruiting
Research Site | Saint-Petersburg, 197022, Russian Federation Not yet recruiting
Research Site | Sankt-Peterburg, 197758, Russian Federation Not yet recruiting
Research Site | Chiayi, 613, Taiwan Recruiting
Research Site | Kaohsiung, 824, Taiwan Recruiting
Research Site | Kaohsiung, 83301, Taiwan Not yet recruiting
Research Site | Taichung, 40705, Taiwan Recruiting
Research Site | Tainan, 704, Taiwan Recruiting
Research Site | Taipei 112, Taiwan Recruiting
Research Site | Taipei City, 10050, Taiwan Recruiting
Research Site | Taoyuan, 333, Taiwan Recruiting
Research Site | Bangkok, 10330, Thailand Recruiting
Research Site | Bangkok, 10400, Thailand Recruiting
Research Site | Chiang Mai, 50200, Thailand Recruiting
Research Site | Khon Kaen, 40002, Thailand Recruiting
Research Site | Sisaket, 33000, Thailand Not yet recruiting
Research Site | Songkla, 90110, Thailand Recruiting
Research Site | Ankara, 06100, Turkey Recruiting
Research Site | Istanbul, 34030, Turkey Recruiting
Research Site | Izmir, 35100, Turkey Recruiting
Research Site | Mersin, 33110, Turkey Recruiting
Research Site | Bristol, BS2 8ED, United Kingdom Suspended
Research Site | Cambridge, CB2 0QQ, United Kingdom Recruiting
Research Site | London, NW3 2QG, United Kingdom Recruiting
Research Site | London, W12 0NN, United Kingdom Suspended
Research Site | Manchester, M20 4BX, United Kingdom Suspended
Research Site | Oxford, OX3 7LE, United Kingdom Not yet recruiting
Research Site | Romford, RM7 0AG, United Kingdom Recruiting
Research Site | Sheffield, S10 2SJ, United Kingdom Suspended
Location Countries

Argentina

Bulgaria

Chile

China

France

Hong Kong

India

Italy

Japan

Korea, Republic of

Poland

Russian Federation

Taiwan

Thailand

Turkey

United Kingdom

United States

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Treatment Arm

Type: Experimental

Description: Durvalumab + Gemcitabine + Cisplatin

Label: Placebo Arm

Type: Placebo Comparator

Description: Placebo + Gemcitabine + Cisplatin

Acronym TOPAZ-1
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Durvalumab in Combination with Gemcitabine plus Cisplatin Placebo in Combination with Gemcitabine plus Cisplatin

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov