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

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT03875235

TOPAZ-1 is a Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy of Durvalumab with gemcitabine/cisplatin versus placebo with gemcitabine/cisplatin in first-line advanced biliary tract cancer. Participants receive IV infusions every 3 weeks for up to 8 cycles, followed by monotherapy every 4 weeks until disease progression or discontinuation.

Patient Parameters

Program Overview

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

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.

Eligibility Criteria

Inclusion

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

Locations

FACILITYZIPCITYSTATE
Research Site90027Los AngelesCalifornia
Research Site92868OrangeCalifornia
Research Site20007Washington D.C.District of Columbia
Research Site33905Fort MyersFlorida
Research Site33705St. PetersburgFlorida
Research Site66205WestwoodKansas
Research Site40202LouisvilleKentucky
Research Site01805BurlingtonMassachusetts
Research Site63110St LouisMissouri
Research Site27514Chapel HillNorth Carolina

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