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Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

AstraZeneca

Conditions:

Biliary Tract Neoplasms

Eligibility:

All Genders

18-130 years

Phase:

PHASE3

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...

Eligibility Criteria

Inclusion

  • Inclusion
  • Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
  • Patients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
  • 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.
  • WHO/ECOG PS of 0 or 1
  • Exclusion
  • History of another primary malignancy
  • Brain metastases or spinal cord compression
  • Uncontrolled intercurrent illness
  • Major surgical procedure within 28 days prior to the first dose of IP.
  • Prior locoregional therapy such as radioembolization

Exclusion

    Key Trial Info

    Start Date :

    April 16 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 31 2025

    Estimated Enrollment :

    810 Patients enrolled

    Trial Details

    Trial ID

    NCT03875235

    Start Date

    April 16 2019

    End Date

    December 31 2025

    Last Update

    October 10 2025

    Active Locations (126)

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    Page 1 of 32 (126 locations)

    1

    Research Site

    Los Angeles, California, United States, 90027

    2

    Research Site

    Orange, California, United States, 92868

    3

    Research Site

    Washington D.C., District of Columbia, United States, 20007

    4

    Research Site

    Fort Myers, Florida, United States, 33905