Gastric CancerPhase 2NCT04656002
As a Second-line Treatment for Metastatic Gastric Adenocarcinoma Patients, the Safety and Effective of Vactosertib Administration in Combination With Paclitaxel+Ramucirumab is Evaluated, and a Phase 2a Clinical Trial to Biomarkers
A Phase 2 study testing Vactosertib in people with Gastric Cancer, run by Samsung Medical Center.
Trial summary
This clinical trial is to evaluate the efficacy and safety of subjects with metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. In addition, this clinical trial is performed to analyze the genome-specific response rate and genome analysis to identify predictive markers that respond to… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Vactosertib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Dec 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed gastric cancer, including gastric adenocarcinoma or GEJ adenocarcinoma.
- Patients with metastatic or locally recurrent unresectable disease.
- Patients with diseased lesions that can be measured using standard computed tomography (CT) or magnetic resonance imaging (MRI).
- Patients who have experienced disease progression during or after primary therapy for metastatic disease.
- Patients over 19 years of age.
- All clinically significant toxic effects of previous chemotherapy, surgery, radiation therapy, or hormone therapy are rated ≤1 (or neuropathic Cases ≤2 grade) (excluding hair loss).
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- Patients with an Eastern Oncology Cooperative Group Performance Status (ECOG PS) score of 0 or 1.
- Total bilirubin ≤1.5 mg/dL (25.65 µmol/L), and aspartic acid aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x upper limit of normal (ULN; or 5.0 x with liver metastasis) Patients with adequate liver function as defined by ULN).
- etc
Who cannot join
- Patients previously receiving treatment targeting the TGF-β signaling pathway
- Patients who previously received Taxane-based chemotherapy
- Patients with recorded and/or symptomatic brain or meningeal metastases.
- Patients who experienced Grade 3-4 GI bleeding within 3 months prior to enrollment.
- Patients who have experienced arterial thromboembolic events including, but not limited to, myocardial infarction, transient ischemic attack, cerebrovascular attack, or unstable angina within 6 months prior to enrollment.
- Ongoing or active infection, symptomatic congestive heart failure, unstable angina, symptomatic or poorly controlled cardiac arrhythmias, uncontrolled thrombotic or hemorrhagic disease, interstitial pneumonia or pulmonary fibrosis, or in the judgment of the treating physician. Patients with other serious medical conditions that are not controlled.
- Patients with ongoing or active psychiatric conditions or social situations that may limit adherence to treatment.
- Patients with uncontrolled or poorly controlled hypertension (systolic >160 mmHg or diastolic >100 mmHg for >4 weeks) despite standard medical care.
Trial locations and contacts
No sites are listed yet.
About this study
This clinical trial is to evaluate the efficacy and safety of subjects with metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. In addition, this clinical trial is performed to analyze the genome-specific response rate and genome analysis to identify predictive markers that respond to investigational drug administration.
Read the detailed description
4 weeks (28 days) administration is considered as 1 cycle.
[Bactosertib／TEW-7197] A 300mg dose is administered orally as tablets twice a day for 5 days, followed by a 2 day holiday. (5 days medication/2 days off). All doses are taken in the morning/evening, approximately 12 hours apart, regardless of food.
[Ramucirumab (ramucirumab)] A dose of 8 mg/kg (8 mg per kg of body weight) is administered once for 60 minutes at the 1st and 15th days of each cycle. This drug is administered directly into a blood vessel using an infusion pump.
[paclitaxel (paclitaxel)] A dose of 80mg/m2 is administered intravenously for 60 minutes at the 1st, 8th, and 15th days of each cycle and is withdrawn for 1 week.
- Conditions
- Gastric Cancer
- Being tested
- 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.
VactosertibDrug
Also called TEW-7197
Take Baektoseotip (TEW-7197) twice a day for 5 days and take a break for 2 days (5D on/2D off). With this method, progression up to the 28th day is taken as one cycle. Take it with or without food every twelve hours
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel, Ramucirumab + TEW-7197 | Experimental | Take Baektoseotip (TEW-7197) twice a day for 5 days and take a break for 2 days (5D on/2D off). With this method, progression up to the 28th day is taken as one cycle. Take it with or without food every twelve hours
-Paclitaxel, Ramucirumab Intravenous (IV) Ramucirumab injection, provided as a single-use 500-mg/50-mL vial containing 10 mg/mL of product in histidine buffer, with disease progression, toxicity requiring discontinuation, or without interruption for any reason. After diluting to 8 mg/kg every 2 weeks, IV It is administered by infusion.
Paclitaxel is administered at a dose of 80 mg/m2 on days 1, 8 and 15 of a 28-day cycle, with disease progression, toxicity requiring discontinuation, or without interruption for any reason. Receives: Drug: Vactosertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: up to 24momths
Secondary outcomes (1)
Disease control rate
Measured: up to 24momths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study startOct 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- TEW-7197 300 mg BID 5D on/2D off \+ Ramucirumab IV 8 mg/kg every 2weeks +Paclitaxel 80 mg/m2 day1.8.15 every 28days
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung tae Kim,PhMD, Samsung Medical Center
- Investigators
- SeungTae Kim, PhMD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656002
- Sponsor's protocol ID
- 2020-05-175
- Status last verified
- Jun 2022
- First submitted
- 30 Nov 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- As a Second-line Treatment for Metastatic Gastric Adenocarcinoma Patients, the Safety and Effective of Vactosertib Administration in Combination With Paclitaxel+Ramucirumab is Evaluated, and a Phase 2a Clinical Trial to Biomarkers
- ClinicalTrials.gov ID
- NCT04656002
- Acronym / sponsor ID
- 2020-05-175
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Dec 2020 (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 clinical trial is to evaluate the efficacy and safety of subjects with metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. In addition, this clinical trial is performed to analyze the genome-specific response rate and genome analysis to identify predictive markers that respond to investigational drug administration.
Detailed description
4 weeks (28 days) administration is considered as 1 cycle.
[Bactosertib／TEW-7197] A 300mg dose is administered orally as tablets twice a day for 5 days, followed by a 2 day holiday. (5 days medication/2 days off). All doses are taken in the morning/evening, approximately 12 hours apart, regardless of food.
[Ramucirumab (ramucirumab)] A dose of 8 mg/kg (8 mg per kg of body weight) is administered once for 60 minutes at the 1st and 15th days of each cycle. This drug is administered directly into a blood vessel using an infusion pump.
[paclitaxel (paclitaxel)] A dose of 80mg/m2 is administered intravenously for 60 minutes at the 1st, 8th, and 15th days of each cycle and is withdrawn for 1 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- TEW-7197 300 mg BID 5D on/2D off + Ramucirumab IV 8 mg/kg every 2weeks +Paclitaxel 80 mg/m2 day1.8.15 every 28days
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel, Ramucirumab + TEW-7197 | Experimental | Drug: VactosertibTake Baektoseotip (TEW-7197) twice a day for 5 days and take a break for 2 days (5D on/2D off). With this method, progression up to the 28th day is taken as one cycle. Take it with or without food every twelve hours -Paclitaxel, Ramucirumab Intravenous (IV) Ramucirumab injection, provided as a single-use 500-mg/50-mL vial containing 10 mg/mL of product in histidine buffer, with disease progression, toxicity requiring discontinuation, or without interruption for any reason. After diluting to 8 mg/kg every 2 weeks, IV It is administered by infusion. Paclitaxel is administered at a dose of 80 mg/m2 on days 1, 8 and 15 of a 28-day cycle, with disease progression, toxicity requiring discontinuation, or without interruption for any reason. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with histologically or cytologically confirmed gastric cancer, including gastric adenocarcinoma or GEJ adenocarcinoma.
- Patients with metastatic or locally recurrent unresectable disease.
- Patients with diseased lesions that can be measured using standard computed tomography (CT) or magnetic resonance imaging (MRI).
- Patients who have experienced disease progression during or after primary therapy for metastatic disease.
- Patients over 19 years of age.
Key exclusion criteria (8 listed)
- Patients previously receiving treatment targeting the TGF-β signaling pathway
- Patients who previously received Taxane-based chemotherapy
- Patients with recorded and/or symptomatic brain or meningeal metastases.
- Patients who experienced Grade 3-4 GI bleeding within 3 months prior to enrollment.
- Patients who have experienced arterial thromboembolic events including, but not limited to, myocardial infarction, transient ischemic attack, cerebrovascular attack, or unstable angina within 6 months prior to enrollment.
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 |
|---|---|---|
| VactosertibAlso: TEW-7197Take Baektoseotip (TEW-7197) twice a day for 5 days and take a break for 2 days (5D on/2D off). With this method, progression up to the 28th day is taken as one cycle. Take it with or without food every twelve hours | Drug | Paclitaxel, Ramucirumab + TEW-7197 |
Primary outcome
Objective response rate
Time frame: up to 24momths
1 secondary outcome
Disease control rate
Time frame: up to 24momths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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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.
SeungTae Kim, PhMD principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vactosertib in people with Gastric Cancer, run by Samsung Medical Center.
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 9 inclusion and 8 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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 SeungTae Kim, PhMD (82-2-3410-3459, seungtae1.kim@samsung.com), 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: up to 24momths). 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 15 Jun 2022.