Status:
RECRUITING
Olaparib With or Without Durvalumab for DDR Gene Mutated Biliary Tract Cancer Following Platinum-based Chemotherapy
Lead Sponsor:
Asan Medical Center
Conditions:
Biliary Tract Cancer
DNA Damage Repair Deficiency
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
First-line gemcitabine plus cisplatin chemotherapy is the standard first-line treatment for unresectable or metastatic advanced biliary tract cancer and the optimal duration of the treatment is not me...
Eligibility Criteria
Inclusion
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Age 19 years and older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 \~ 1
- Patients must have a life expectancy ≥ 16 weeks.
- Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, or gallbladder carcinoma).
- Locally advanced unresectable, recurrence after curative surgery or metastatic disease
- At least 16 weeks of continuous first-line platinum-based chemotherapy for unresectable or metastatic disease
- Somatic or germline mutation of at least one the DNA damage repair gene including ATM, ATR, BAP1, BARD1, BLM, BRCA1, BRCA2, BRIP1, CHEK1, CHEK2, GEN1, FANCA, FANCD2, POLE, MLH1, MSH2, MSH6, MRE11A, NBN, PALB2, PMS2, RAD50, RAD51, RAD51C, RAD51D, and XRCC2 confirmed by targeted exome sequencing
- Measurable disease is not necessarily needed for enrollment.
- No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy.
- Normal organ and bone marrow function measured within 28 days prior to administration of study treatment including haemoglobin ≥10.0 g/dL with no blood transfusion in the past 28 days, platelets ≥ 100 x 109/L, neutrophils ≥ 1.5 x 109/L, creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test ,serum total bilirubin ≤ 1.5 x ULN and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 x ULN
- No other malignant disease apart from adequately treated non-melanotic skin cancer, curatively treated carcinoma in situ of the uterine cervix, localized prostate or papillary thyroid cancer, or any other cancer where treated with curative intent \> 5 years previously without evidence of relapse
- Written, informed consent to the study
- Body weight \>30kg
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Exclusion
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05222971
Start Date
April 1 2022
End Date
December 30 2026
Last Update
January 28 2025
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505