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

NCT03579784 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-19

No results posted yet for this study

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

Conditions

  • Advanced Gastric Cancer

Interventions

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 mg iv on D1, D8, D15 Every 4 weeks

DRUG

Olaparib

Olaparib 150mg bid on D1-28 Every 4 weeks

DRUG

Durvalumab

Durvalumab 1.5 g iv on D1 Every 4 weeks

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Do-Youn Oh

    lead OTHER

Principal Investigators

  • Do-Youn Oh, MD, PhD · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03579784 on ClinicalTrials.gov