NCT04893252

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

2.6 years

First QC Date

May 10, 2021

Last Update Submit

November 29, 2022

Conditions

Stomach Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Objective response rate in 55 participants according to RECIST v1.1

    Every 8 weeks from the date of the first dose until the date of progression, assessed up to 1 year

Study Arms (1)

vactosertib in combination with durvalumab

EXPERIMENTAL

single arm study

Drug: durvalumab and vactosertib

Interventions

durvalumab and vactosertibDRUG

durvalumab IV Q4W in combination with vactosertib PO bid (5 days a week)

vactosertib in combination with durvalumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior ALK5 inhibitor treatment
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
  • Patients weighing \<30kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

durvalumabvactosertib

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Hark K Kim, MD,PhD

CONTACT

+82-31-920-2238hkim@ncc.re.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 19, 2021

Study Start

June 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

November 30, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)