drugset / Trial / NCT03579784
Biomarker-oriented Study of Durvalumab (MEDI4736) in Combination With Olaparib and Paclitaxel in Gastric Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1.5 g | Intravenous |
| Background | Olaparib | Small molecule | 150 mg | — |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |