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

  • STATUS
    Recruiting
  • participants needed
    74
  • sponsor
    Seoul National University Hospital
Updated on 25 May 2022
platelet count
cancer
hysterectomy
measurable disease
MRI
serum bilirubin
neutrophil count
blood transfusion
follicle stimulating hormone
durvalumab
olaparib
azd6738
advanced biliary tract carcinoma
gallbladder cancer
intrahepatic bile duct carcinoma
biliary tract cancer
ampullary carcinoma
ampulla of vater cancer

Summary

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.

Description

This is a open-label, phase II, umbrella study enrolling advanced biliary tract cancer patients who have failed to 1st-line chemotherapy. Patients will be enrolled to AZD6738 and Durvalumab combination or AZD6738 and Olaparib combination cohorts. Based on the new emerging therapies, cohorts can be added into existing protocol.

  1. AZD6738 + Durvalumab cohort:
    • 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.
  2. AZD6738 + Olaparib cohort:
    • 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.

One cycle consists of 4weeks. Response evaluation will be done every 8 weeks (every 2 cycles) of treatment

  1. tumor biopsy is mandatory : screening, after 8weeks (1st-response evaluation), at disease progression (PD)
  2. blood sampling for biomarker study is mandatory: every cycles
  3. To evaluate the metabolic changes, 18 F-FDG PET is mandatory at screening and after 8 weeks (1st-response evaluation).

Details
Condition Cholangiocarcinoma, Biliary neoplasm, cancer of the bile duct, Bile duct carcinoma, Chemotherapy Effect, Biliary Tract Cancer, Urothelial Tract Cancer
Treatment durvalumab, olaparib, AZD6738
Clinical Study IdentifierNCT04298021
SponsorSeoul National University Hospital
Last Modified on25 May 2022

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