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Trial record 1 of 1 for:    NCT03875235
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Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) (TOPAZ-1)

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ClinicalTrials.gov Identifier: NCT03875235
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Biliary Tract Neoplasms Drug: Durvalumab Drug: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Durvalumab in Combination with Gemcitabine plus Cisplatin Placebo in Combination with Gemcitabine plus Cisplatin
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : March 25, 2022
Estimated Study Completion Date : March 25, 2022


Arm Intervention/treatment
Experimental: Treatment Arm
Durvalumab + Gemcitabine + Cisplatin
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.

Placebo Comparator: Placebo Arm
Placebo + Gemcitabine + Cisplatin
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.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 36 months ]
    Assessments for Overall survival will be collected regularly at predefined time points until death


Secondary Outcome Measures :
  1. PFS according to RECIST 1.1 using investigator assessment [ Time Frame: 36 months ]
    Assessments will be made regularly until disease progression or until the end of the study

  2. ORR according to RECIST 1.1 using investigator assessment [ Time Frame: 36 months ]
    Assessments will be made regularly until disease progression or until the end of the study

  3. DoR according to RECIST 1.1 using investigator assessment [ Time Frame: 36 months ]
    Assessments will be made regularly until disease progression or until the end of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875235


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service 1-877-400-4656 AstraZeneca@emergingmed.com

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Locations
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United States, California
Research Site Withdrawn
Duarte, California, United States, 91010
Research Site Recruiting
Los Angeles, California, United States, 90027
Research Site Recruiting
Orange, California, United States, 92868
Research Site Not yet recruiting
San Francisco, California, United States, 94115
United States, District of Columbia
Research Site Not yet recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Research Site Not yet recruiting
Fort Myers, Florida, United States, 33905
Research Site Not yet recruiting
Saint Petersburg, Florida, United States, 33705
United States, Kansas
Research Site Not yet recruiting
Westwood, Kansas, United States, 66205
United States, Kentucky
Research Site Not yet recruiting
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Research Site Not yet recruiting
Burlington, Massachusetts, United States, 01805
United States, Missouri
Research Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Research Site Not yet recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Oregon
Research Site Not yet recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
Research Site Not yet recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Research Site Not yet recruiting
Chattanooga, Tennessee, United States, 37404
Research Site Withdrawn
Nashville, Tennessee, United States, 37203
Research Site Not yet recruiting
Nashville, Tennessee, United States, 37203
United States, Washington
Research Site Not yet recruiting
Seattle, Washington, United States, 98109
Argentina
Research Site Not yet recruiting
Buenos Aires, Argentina, C1118AAT
Research Site Not yet recruiting
Buenos Aires, Argentina, C1426ANZ
Research Site Withdrawn
Cordoba, Argentina, 5001
Research Site Not yet recruiting
Rosario, Argentina, 2000
Research Site Recruiting
San Salvador de Jujuy, Argentina, 4600
Bulgaria
Research Site Not yet recruiting
Burgas, Bulgaria, 8000
Research Site Not yet recruiting
Pleven, Bulgaria, 5800
Research Site Not yet recruiting
Sofia, Bulgaria, 1330
Research Site Not yet recruiting
Sofia, Bulgaria
Research Site Not yet recruiting
Varna, Bulgaria, 9010
Chile
Research Site Not yet recruiting
Puerto Montt, Chile, 5480000
Research Site Not yet recruiting
Santiago, Chile, 7630370
Research Site Withdrawn
Santiago, Chile, 8380455
Research Site Not yet recruiting
Santiago, Chile, 8380456
Research Site Not yet recruiting
Temuco, Chile, 4810218
Research Site Not yet recruiting
Viña del Mar, Chile, 2540488
France
Research Site Recruiting
Dijon Cedex, France, 21079
Research Site Not yet recruiting
Montpellier CEDEX 5, France, 34295
Research Site Not yet recruiting
Nice, France, 6189
Research Site Not yet recruiting
PARIS Cedex 12, France, 75571
Research Site Not yet recruiting
Pessac, France, 33604
Research Site Not yet recruiting
Poitiers, France, 86021
Research Site Not yet recruiting
Reims, France, 51092
Research Site Not yet recruiting
Villejuif Cedex, France, 94805
Hong Kong
Research Site Not yet recruiting
Hong Kong, Hong Kong
Research Site Not yet recruiting
HongKong, Hong Kong
Research Site Not yet recruiting
Kowloon, Hong Kong
Italy
Research Site Not yet recruiting
Faenza, Italy, 48018
Research Site Not yet recruiting
Firenze, Italy, 50134
Research Site Not yet recruiting
Milano, Italy, 20132
Research Site Not yet recruiting
Napoli, Italy, 80131
Research Site Not yet recruiting
Roma, Italy, 00168
Research Site Not yet recruiting
San Giovanni Rotondo, Italy, 71013
Research Site Not yet recruiting
Verona, Italy, 37134
Japan
Research Site Recruiting
Chuo-ku, Japan, 104-0045
Research Site Recruiting
Kashiwa, Japan, 227-8577
Research Site Recruiting
Kitaadachi-gun, Japan, 362-0806
Research Site Not yet recruiting
Mitaka-shi, Japan, 181-8611
Research Site Recruiting
Osaka-shi, Japan, 541-8567
Research Site Recruiting
Suita-shi, Japan, 565-0871
Research Site Recruiting
Wakayama-shi, Japan, 641-8510
Research Site Recruiting
Yokohama-shi, Japan, 241-8515
Korea, Republic of
Research Site Recruiting
Seongnam-si, Korea, Republic of, 13620
Research Site Recruiting
Seoul, Korea, Republic of, 03080
Research Site Recruiting
Seoul, Korea, Republic of, 03722
Research Site Recruiting
Seoul, Korea, Republic of, 06351
Research Site Recruiting
Seoul, Korea, Republic of, 06591
Research Site Recruiting
Seoul, Korea, Republic of, 152-703
Poland
Research Site Recruiting
Gdańsk, Poland, 80-214
Research Site Not yet recruiting
Kościerzyna, Poland, 83-400
Research Site Not yet recruiting
Poznan, Poland, 60-780
Research Site Withdrawn
Warszawa, Poland, 02-097
Research Site Recruiting
Wrocław, Poland, 50-556
Research Site Recruiting
Łódź, Poland, 93-513
Taiwan
Research Site Recruiting
Kaohsiung, Taiwan, 824
Research Site Recruiting
Taichung, Taiwan, 40705
Research Site Not yet recruiting
Tainan, Taiwan, 704
Research Site Not yet recruiting
Taipei City, Taiwan, 10050
Research Site Recruiting
Taipei, Taiwan, 11217
Research Site Recruiting
Taoyuan, Taiwan, 333
Thailand
Research Site Not yet recruiting
Bangkok, Thailand, 10330
Research Site Not yet recruiting
Bangkok, Thailand, 10400
Research Site Not yet recruiting
Khon Kaen, Thailand, 40002
Research Site Recruiting
Muang, Thailand, 50200
Research Site Not yet recruiting
Songkla, Thailand, 90110
Turkey
Research Site Recruiting
Ankara, Turkey, 06100
Research Site Recruiting
Istanbul, Turkey, 34030
Research Site Recruiting
Izmir, Turkey, 35100
Research Site Recruiting
Mersin, Turkey, 33110
United Kingdom
Research Site Not yet recruiting
Bristol, United Kingdom, BS2 8ED
Research Site Recruiting
Cambridge, United Kingdom, CB2 0QQ
Research Site Recruiting
London, United Kingdom, W12 0NN
Research Site Recruiting
London, United Kingdom, W1P 8BT
Research Site Recruiting
Manchester, United Kingdom, M20 4BX
Research Site Recruiting
Romford, United Kingdom, RM7 0AG
Research Site Recruiting
Sheffield, United Kingdom, S10 2SJ
Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03875235     History of Changes
Other Study ID Numbers: D933AC00001
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AstraZeneca:
First-Line Advanced Biliary Tract Cancers (BTC)
Durvalumab
Gemcitabine/Cisplatin
Placebo
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Cisplatin
Durvalumab
Antibodies, Monoclonal
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological