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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03875235
Recruitment Status : Active, not recruiting
First Posted : March 14, 2019
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 810 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
Actual Primary Completion Date : August 11, 2021
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 40 months ]

Secondary Outcome Measures :
  1. PFS according to RECIST 1.1 using investigator assessment [ Time Frame: 40 months ]
  2. ORR according to RECIST 1.1 using investigator assessment [ Time Frame: 40 months ]
  3. DoR according to RECIST 1.1 using investigator assessment [ Time Frame: 40 months ]
  4. EORTC QLQ-C30 and EORTC QLQ-BIL21 [ Time Frame: 40 months ]
  5. PFS, ORR, DoR, and DCR according to RECIST 1.1 using Investigator assessments and OS by PD-L1 expression [ Time Frame: 40 months ]
  6. Serum concentration of durvalumab (peak and trough concentration) [ Time Frame: 40 months ]
  7. Tiered results of ADAs for durvalumab [ Time Frame: 40 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Gordon Cohen AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03875235    
Other Study ID Numbers: D933AC00001
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: 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
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents