Stomach NeoplasmPhase 2NCT04893252
Vactosertib and Durvalumab in Gastric Cancer
A Phase 2 study testing durvalumab and vactosertib in people with Stomach Neoplasm, run by Hark Kyun Kim at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasm
- What is being tested?
- durvalumab and vactosertib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior ALK5 inhibitor treatment
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
- Patients weighing <30kg
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Hark K Kim, MD,PhD, +82-31-920-2238, hkim@ncc.re.kr
Hyegyung Chang, RN, +82-31-920-2233, jhk@ncc.re.kr
About this study
Official title: Vactosertib in Combination With Durvalumab (MEDI4736) in Patients With Gastric Cancer
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
Read the 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.
- Conditions
- Stomach Neoplasm
- Being tested
- durvalumab and vactosertib
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
durvalumab and vactosertibDrug
durvalumab IV Q4W in combination with vactosertib PO bid (5 days a week)
| Study group | Role | What they receive |
|---|---|---|
| vactosertib in combination with durvalumab | Experimental | single arm study Receives: Drug: durvalumab and vactosertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate in 55 participants according to RECIST v1.1
Measured: Every 8 weeks from the date of the first dose until the date of progression, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hark Kyun Kim
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Hark Kyun Kim, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893252
- Sponsor's protocol ID
- 33737
- Status last verified
- Nov 2022
- First submitted
- 10 May 2021
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vactosertib in Combination With Durvalumab (MEDI4736) in Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT04893252
- Acronym / sponsor ID
- 33737
- Conditions
- Stomach Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Hark Kyun KimOther government
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vactosertib in combination with durvalumab | Experimental | Drug: durvalumab and vactosertibsingle arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Prior ALK5 inhibitor treatment
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
- Patients weighing <30kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| durvalumab and vactosertibdurvalumab IV Q4W in combination with vactosertib PO bid (5 days a week) | Drug | vactosertib in combination with durvalumab |
Primary outcome
Objective response rate
Time frame: Every 8 weeks from the date of the first dose until the date of progression, assessed up to 1 year
Objective response rate in 55 participants according to RECIST v1.1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing durvalumab and vactosertib in people with Stomach Neoplasm, run by Hark Kyun Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hark K Kim, MD,PhD (+82-31-920-2238, hkim@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Every 8 weeks from the date of the first dose until the date of progression, assessed up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.