DDR-Umbrella Study of DDR Targeting Agents in Advanced Biliary Tract Cancer

Sponsor
Seoul National University Hospital
Study ID
NCT04298021
Phase
PHASE2
Status
Unknown

Conditions

  • Bile Duct Cancer
  • Chemotherapy Effect

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD6738 — DRUG
    * In AZD6738+Durvalumab cohort \- AZD6738 240 mg bid on D15-D28 Every 4 weeks * In AZD6738+ Olaparib cohort - AZD6738 160 mg qd on D1-7 Every 4 weeks
  • Durvalumab — DRUG
    Durvalumab 1500 mg iv on D1 Every 4 weeks
  • Olaparib — DRUG
    Olaparib 300 mg bid on D1-28 Every 4 weeks

Study Details

To assess the effect of AZD6738 and Durvalumab combination or AZD6738 and Olaparib combination in biliary tract cancer patients who have failed to 1st-line chemotherapy.

Key Dates

First listed
Mar 6, 2020
Start date
Jun 25, 2020
Status verified
Apr 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
74 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD6738 + Durvalumab
    * Durvalumab 1500 mg iv on D1 * AZD6738 240 mg bid on D15-D28 Every 4 weeks C1D1 dose of durvalumab will be delivered, and AZD6738 of 240 mg bid will be dosed at D15-D28. Every cycle consists of 4 weeks.
  • Experimental: AZD6738 + Olaparib
    * AZD6738 160 mg qd on D1-D7 * Olaparib 300 mg bid on D1-D28 Every 4 weeks Every cycle consists of 4 weeks. AZD6738 of 160 mg qd will be administered on D1-D7. Olaparib will be delivered as 300 mg bid dose on D1-D28.

Primary Outcome Measure

Disease control rate of AZD6738 + Durvalumab cohort [ Time Frame: through study completion, an average of 1 year ]

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