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

Part of paid clinical trials in Los Angeles, California.

Sponsor
AstraZeneca
Study ID
NCT03875235
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Biliary Tract Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    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 — DRUG
    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.

Study Details

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

Key Dates

Start date
Apr 16, 2019
Status verified
May 2026
Primary completion
Aug 11, 2021
Completion
May 16, 2027

Study Design

Enrollment
810 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Durvalumab + Gemcitabine + Cisplatin
  • Placebo Comparator: Placebo Arm
    Placebo + Gemcitabine + Cisplatin

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of randomization until death due to any cause. Assessed up to maximum of approximately 27 months (from date of randomization to primary analysis data cut-off) ]

Locations (15)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90027-
Research SiteOrangeCalifornia92868-
Research SiteWashington D.C.District of Columbia20007-
Research SiteFort MyersFlorida33905-
Research SiteSt. PetersburgFlorida33705-
Research SiteWestwoodKansas66205-
Research SiteLouisvilleKentucky40202-
Research SiteBurlingtonMassachusetts01805-
Research SiteSt LouisMissouri63110-
Research SiteChapel HillNorth Carolina27514-
Research SitePortlandOregon97213-
Research SitePhiladelphiaPennsylvania19111-
Research SiteChattanoogaTennessee37404-
Research SiteNashvilleTennessee37203-
Research SiteSeattleWashington98109-

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