NCT04298021

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

DDR-Umbrella Study of DDR (DNA-Damage Response) Targeting Agents in Advanced Biliary Tract Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Bile Duct Cancer
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	AZD6738	* 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
DRUG	Durvalumab	Durvalumab 1500 mg iv on D1 Every 4 weeks
DRUG	Olaparib	Olaparib 300 mg bid on D1-28 Every 4 weeks

Timeline

• Start date: 2020-06-25
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-03-06
• Last updated: 2024-04-19

Locations

1 site across 1 country: South Korea