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

Sponsor
Do-Youn Oh
Study ID
NCT03579784
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    Paclitaxel 80 mg/m2 mg iv on D1, D8, D15 Every 4 weeks
  • Olaparib — DRUG
    Olaparib 150mg bid on D1-28 Every 4 weeks
  • Durvalumab — DRUG
    Durvalumab 1.5 g iv on D1 Every 4 weeks

Study Details

\<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

Key Dates

Start date
Nov 26, 2018
Status verified
Apr 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab+Olaparib+Paclitaxel
    1. st cycle : Paclitaxel+Olaparib * Olaparib 150mg bid on D1-28 * Paclitaxel 80 mg/m2 mg iv on D1, D8, D15 2. nd cycle and thereafter: Durvalumab+Olaparib+Paclitaxel : * Olaparib 150mg bid on D1-28 * Durvalumab 1.5 g iv on D1 * Paclitaxel 80 mg/m2 mg iv on D1, D8, D15 Every 4 weeks During first 4 weeks, palictaxel/olaparib dual combination will be used. Since 2nd cycle, palictaxel/olaparib/Durvalumab combination will be used.

Primary Outcome Measure

Disease control rate [ Time Frame: 8weeks ]

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