Active — Not RecruitingPhase 3

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

United States810 participantsStarted 2019-04-16

Plain-language summary

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

Who can participate

Age range18 Years – 130 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Overall Survival (OS)

Timeframe: 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)

Overall Survival (OS) Rate at 18 Months

Timeframe: From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique.

Overall Survival (OS) Rate at 24 Months

Timeframe: From date of randomization until death due to any cause. Calculated at 24 months using the Kaplan-Meier technique.

Trial details

NCT IDNCT03875235

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-11

Results submitted2022-08-10

View on ClinicalTrials.gov More Biliary Tract Neoplasms trials