drugset / Trial / NCT03579784

Biomarker-oriented Study of Durvalumab (MEDI4736) in Combination With Olaparib and Paclitaxel in Gastric Cancer

NCT03579784

Phase 2 Unknown 40 enrolled Do-Youn Oh AstraZeneca · collab
NaSingle-groupOpen-labelTreatment

Summary

\<Research Hypothesis\> The dynamics of immune systems by Olaparib and its changes by combination with immune-oncology agents will be uncovered. The combination of Olaparib with Durvalumab with paclitaxel is tolerable and efficacious in gastric cancer. \<Objectives\> Primary Objectives: To assess the effect of Durvalumab in combination with olaparib and paclitaxel on DCR (Disease control rate) in gastric cancer patients -Disease control rate (based on RECIST v1.1) Secondary Objective(s): * Efficacy: overall response rate (RECIST 1.1, ir response), progression-free survival, duration of response, overall survival, overall survival at 6 month, overall survival at 1 year, EORTC QLQ-C30, * Safety: toxicity (CTCAE V4.1), irAE

Timeline

Start
2018-11-26
Primary completion
2024-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1.5 g Intravenous
Background Olaparib Small molecule 150 mg
Background Paclitaxel Small molecule 80 mg/m2 Intravenous

Indications