Gastric CancerPhase 1NCT04454476
Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor
A Phase 1 study testing Trametinib treatment and Endoscopy in people with Gastric Cancer and Metaplasia, run by Vanderbilt-Ingram Cancer Center at 3 sites in Japan.
Trial summary
This is a study of the safety and effectiveness of Trametinib treatment in patients who have received successful endoscopic submucosal resection of a Stage I gastric cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer, Metaplasia, Stage I Gastric Cancer
- What is being tested?
- Trametinib treatment and Endoscopy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesJapan
- Study dates
- 9 Nov 2022to Dec 2025
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary registration
- Person having intact stomach after treatment of early gastric cancer or gastric adenoma
- Person whose treated gastric cancer histological type is intestinal type.
- Person whose treated gastric cancer or gastric adenoma was curatively resected.
- Person who does not have symptoms of gastric cancer recurrence.
- Person who can declare agreement for enrollment by understanding the study and signing the informed consent document after hearing the explanation.
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- Person who can visit the hospital in accordance with the schedule.
- Secondary registration
- Person who has gastric atrophy at endoscopy.
- Person who does not have symptoms of gastric cancer recurrence by endoscopy.
- Person who has intestinal metaplasia in stomach, histologically confirmed in biopsy specimens taken under endoscopy within 8 weeks prior to taking MEK inhibitor, Trametinib.
Who cannot join
- Person whose treated gastric cancer was diffuse or signet ring cancer.
- Person whose treated gastric cancer or gastric adenoma was not curatively resected.
- Person who has the history of other malignant disease.
- Person who had a significant improvement in metaplasia after eradication therapy for Helicobacter pylori within one year.
- Person who had plan of eradication Helicobacter pylori in 1 year 9 months
- Person who has history of previous Trametinib or other MEK inhibitor use.
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- Person who has history of hypersensitivity to excipients.
- Person who entered clinical trial and took investigational new drug within 12 weeks.
- Presence of active infection other than chronic gastritis.
- Cardiac conditions as follows:
- Uncontrolled hypertension (BP>=150/95 mm Hg despite medical therapy)
- Acute myocardial infection within 6 months prior to starting treatment
- Uncontrolled Angina (Canadian Cardiovascular Society grade II-IV even after medication)
- Symptomatic heart failure NYHA Class II-IV
- <45% in the past
- Severe valvular disease
- <55% at present
- Atrial fibrilation in ECG with BPM=>100 Laboratory values as listed below (SI units) Absolute Neutrophil Count <1.5x10A9/L (1500 per mm3) Platelets <100x10A9/L (100,000 per mm3) Hemoglobin<=9.0 g /dL Serum creatinine >1.5 X upper limit of normal (ULN) Serum bilirubin >1.5 x ULN AST or ALT > 2.5 x ULN
- Ophthalmological conditions as follows:
- Current or past history of retinal pigment epithelial detachment (RPED)/central serous retinopathy (CSR) or retinal vein occlusion Intraocular pressure (IOP) > 21 mmHg or uncontrolled glaucoma (irrespective of IOP)
- Male or female patients of reproductive potential and, as judged by the investigator, are not employing an effective method of birth control and pregnant female.
- Breast feeding female Have refractory nausea and vomiting , chronic gastrointestinal diseases (e.g . inflammatory bowel disease), or significant bowel resection that would adversely affect the absorption / bioavailability of the orally administered study medication.
- Person who has history of hyperrefractory for Trametinib methyl sulfoxide Person who has pneumonia under chest X-ray. Have evidence of any other significant clinical disorder or laboratory finding that, as judgedby the investigator, makes it undesirable for the patient to participate in the study.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Nagasaki University Hospital
Nagasaki
Nihon University School of Medicine
Tokyo
University of Tokyo Medical Center
Tokyo
About this study
Official title: Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor Treatment
This is a study of the safety and effectiveness of Trametinib treatment in patients who have received successful endoscopic submucosal resection of a Stage I gastric cancer.
Read the detailed description
Objectives:
- To evaluate the efficacy of Trametinib in reversing metaplasia in participants with Stage 1 gastric cancer
- To evaluate the safety of Trametinibin in Stage I gastric cancer patients
- Being tested
- Trametinib treatment, Endoscopy
- Medical subject headings
- Stomach Neoplasms, Metaplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trametinib treatmentDrug
1 mg taken by mouth once a day for 14 days
EndoscopyProcedure or surgery
A tiny camera on the end of a long, flexible tube will be used to examine the stomach and take biopsies.
| Study group | Role | What they receive |
|---|---|---|
| Trametinib treatment | Experimental | Not described Receives: Drug: Trametinib treatment; Procedure: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Trametinib in reversing metaplasia: changes in cell lineages
The ability of Trametinib treatment to decrease the presence of metaplastic cell lineages in biopsies of the lining of the stomach, while also allowing the return of normal cell lineages (i.e. acid-secreting parietal cells). Cell lineages will be identified by immunostaining of tissue sections from biopsies.
Measured: About 12 months
Safety of Trametinib treatment: adverse events
Assessment of side effects induced during or after treatment with Trametinib.
Measured: About 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start9 Nov 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Goldenring, Vanderbilt-Ingram Cancer Center
- Investigators
- James Goldenring, MD, Principal investigator, Vanderbilt Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454476
- Sponsor's protocol ID
- VICC GI 2049
- Status last verified
- Jul 2024
- First submitted
- 24 Jun 2020
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor Treatment
- ClinicalTrials.gov ID
- NCT04454476
- Acronym / sponsor ID
- VICC GI 2049
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Jul 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 is a study of the safety and effectiveness of Trametinib treatment in patients who have received successful endoscopic submucosal resection of a Stage I gastric cancer.
Detailed description
Objectives:
- To evaluate the efficacy of Trametinib in reversing metaplasia in participants with Stage 1 gastric cancer
- To evaluate the safety of Trametinibin in Stage I gastric cancer patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trametinib treatment | Experimental | Drug: Trametinib treatment, Procedure: Endoscopy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Primary registration
- Person having intact stomach after treatment of early gastric cancer or gastric adenoma
- Person whose treated gastric cancer histological type is intestinal type.
- Person whose treated gastric cancer or gastric adenoma was curatively resected.
- Person who does not have symptoms of gastric cancer recurrence.
Key exclusion criteria (23 listed)
- Person whose treated gastric cancer was diffuse or signet ring cancer.
- Person whose treated gastric cancer or gastric adenoma was not curatively resected.
- Person who has the history of other malignant disease.
- Person who had a significant improvement in metaplasia after eradication therapy for Helicobacter pylori within one year.
- Person who had plan of eradication Helicobacter pylori in 1 year 9 months
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 |
|---|---|---|
| Trametinib treatment1 mg taken by mouth once a day for 14 days | Drug | Trametinib treatment |
| EndoscopyA tiny camera on the end of a long, flexible tube will be used to examine the stomach and take biopsies. | Procedure or surgery | Trametinib treatment |
Primary outcome
Effectiveness of Trametinib in reversing metaplasia: changes in cell lineages
Time frame: About 12 months
The ability of Trametinib treatment to decrease the presence of metaplastic cell lineages in biopsies of the lining of the stomach, while also allowing the return of normal cell lineages (i.e. acid-secreting parietal cells). Cell lineages will be identified by immunostaining of tissue sections from biopsies.
Safety of Trametinib treatment: adverse events
Time frame: About 12 weeks
Assessment of side effects induced during or after treatment with Trametinib.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- 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.
James Goldenring, MD principal investigator
Vanderbilt Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trametinib treatment and Endoscopy in people with Gastric Cancer and Metaplasia, run by Vanderbilt-Ingram Cancer Center at 3 sites in Japan.
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 11 inclusion and 23 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Trametinib in reversing metaplasia: changes in cell lineages (time frame: About 12 months). The study lists 2 primary outcomes in all. 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 31 Jul 2024.