Back to resultsVactosertib and Durvalumab in Gastric Cancer
Primary Purpose
Stomach Neoplasm
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
durvalumab and vactosertib
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Have histologically- or cytologically-confirmed diagnosis of metastatic gastric adenocarcinoma in the stomach and gastroesophageal junction that are refractory to at least two lines of treatment.
- Have a performance status of 0-1 on the ECOG Performance Scale.
- Have measurable disease at least one investigator-assessed measurable disease per RECIST v1.1
- Have adequate organ functions
Exclusion Criteria:
- Prior ALK5 inhibitor treatment
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
- Patients weighing <30kg
Sites / Locations
- National Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vactosertib in combination with durvalumab
Arm Description
single arm study
Outcomes
Primary Outcome Measures
Objective response rate
Objective response rate in 55 participants according to RECIST v1.1
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04893252
Brief Title
Vactosertib and Durvalumab in Gastric Cancer
Official Title
Vactosertib in Combination With Durvalumab (MEDI4736) in Patients With Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hark Kyun Kim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This trial will test the efficacy and safety of durvalumab in combination with vactosertib in patients with metastatic gastric cancers who failed ≥ 2 lines of chemotherapy
Detailed Description
Efficacy and safety of durvalumab (anti-PD-L1) via IV infusion Q4W, in combination with vactosertib (TGF-beta inhibitor) PO bid for 5 days a week for up to a maximum of 12 months, will be tested in patients with metastatic hypermutated gastric cancers as ≥ 3rd-line setting until confirmed disease progression, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vactosertib in combination with durvalumab
Arm Type
Experimental
Arm Description
single arm study
Intervention Type
Drug
Intervention Name(s)
durvalumab and vactosertib
Intervention Description
durvalumab IV Q4W in combination with vactosertib PO bid (5 days a week)
Primary Outcome Measure Information:
Title
Objective response rate
Description
Objective response rate in 55 participants according to RECIST v1.1
Time Frame
Every 8 weeks from the date of the first dose until the date of progression, assessed up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have histologically- or cytologically-confirmed diagnosis of metastatic gastric adenocarcinoma in the stomach and gastroesophageal junction that are refractory to at least two lines of treatment.
Have a performance status of 0-1 on the ECOG Performance Scale.
Have measurable disease at least one investigator-assessed measurable disease per RECIST v1.1
Have adequate organ functions
Exclusion Criteria:
Prior ALK5 inhibitor treatment
Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
Patients weighing <30kg
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hark K Kim, MD,PhD
Phone
+82-31-920-2238
Email
hkim@ncc.re.kr
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hark K Kim, MD,PhD
Phone
+82-31-920-2238
Email
hkim@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Hyegyung Chang, RN
Phone
+82-31-920-2233
Email
jhk@ncc.re.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vactosertib and Durvalumab in Gastric Cancer
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