Clinical Trials /

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

NCT03875235

Description:

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

Related Conditions:
  • Biliary Tract Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: D933AC00001
  • NCT ID: NCT03875235

Conditions

  • Biliary Tract Neoplasms

Interventions

DrugSynonymsArms
DurvalumabTreatment Arm
PlaceboPlacebo Arm

Purpose

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
    

Trial Arms

NameTypeDescriptionInterventions
Treatment ArmExperimentalDurvalumab + Gemcitabine + Cisplatin
  • Durvalumab
Placebo ArmPlacebo ComparatorPlacebo + Gemcitabine + Cisplatin
  • Placebo

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
      
Maximum Eligible Age:130 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival
Time Frame:36 months
Safety Issue:
Description:Assessments for Overall survival will be collected regularly at predefined time points until death

Secondary Outcome Measures

Measure:PFS according to RECIST 1.1 using investigator assessment
Time Frame:36 months
Safety Issue:
Description:Assessments will be made regularly until disease progression or until the end of the study
Measure:ORR according to RECIST 1.1 using investigator assessment
Time Frame:36 months
Safety Issue:
Description:Assessments will be made regularly until disease progression or until the end of the study
Measure:DoR according to RECIST 1.1 using investigator assessment
Time Frame:36 months
Safety Issue:
Description:Assessments will be made regularly until disease progression or until the end of the study

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AstraZeneca

Trial Keywords

  • First-Line Advanced Biliary Tract Cancers (BTC)
  • Durvalumab
  • Gemcitabine/Cisplatin
  • Placebo

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