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

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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