Vactosertib and Durvalumab in Gastric Cancer | NCT04893252

Studies
Vactosertib and Durvalumab in Gastric Cancer

NCT04893252

Sponsor

Hark Kyun Kim

Status

Unknown status

Last Update Posted

Nov 30, 2022Actual

Enrollment

55Estimated

Phase

Phase 2

Conditions

Stomach Neoplasm

Interventions

durvalumab and vactosertib

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

May 10, 2021

First Submission Date that Met QC Criteria

May 14, 2021

First Posted Date

May 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2022

Last Update Posted Date

Nov 30, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vactosertib in combination with durvalumab	Experimental	single arm study	Drug: durvalumab and vactosertib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
durvalumab and vactosertib	Drug	durvalumab IV Q4W in combination with vactosertib PO bid (5 days a week)	vactosertib in combination with durvalumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hark K Kim, MD,PhD	Contact	+82-31-920-2238		hkim@ncc.re.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center	Recruiting	Goyang-si	Gyeonggi-do	10408	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000613593	durvalumab
C000590371	vactosertib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided