Trials / Active Not Recruiting
Active Not RecruitingNCT03579784
Biomarker-oriented Study of Durvalumab (MEDI4736) in Combination With Olaparib and Paclitaxel in Gastric Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Do-Youn Oh · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-11-26
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2018-07-09
- Last updated
- 2024-04-19
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03579784. Inclusion in this directory is not an endorsement.