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Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04454476
Recruitment Status : Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : November 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
James Goldenring, Vanderbilt-Ingram Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Metaplasia Stage I Gastric Cancer Initial-onset Gastric Cancer Drug: Trametinib treatment Procedure: Endoscopy Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor Treatment
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Trametinib

Arm Intervention/treatment
Experimental: Trametinib treatment Drug: Trametinib treatment
1 mg taken by mouth once a day for 14 days

Procedure: Endoscopy
A tiny camera on the end of a long, flexible tube will be used to examine the stomach and take biopsies.




Primary Outcome Measures :
  1. 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.

  2. Safety of Trametinib treatment: adverse events [ Time Frame: About 12 weeks ]
    Assessment of side effects induced during or after treatment with Trametinib.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04454476


Contacts
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Contact: James Goldenring, MD 615-936-3726 jim.goldenring@vumc.org

Locations
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Japan
Nihon University School of Medicine
Tokyo, Japan
Contact: Takuji Gotoda       takujigotoda@yahoo.com.jp   
Principal Investigator: Takuji Gotoda         
University of Tokyo Medical Center
Tokyo, Japan
Contact: Sachiyo Nomura       snomura-gi@umin.ac.jp   
Principal Investigator: Sachiyo Nomura         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: James Goldenring, MD Vanderbilt Medical Center
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Responsible Party: James Goldenring, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT04454476    
Other Study ID Numbers: VICC GI 2049
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Stomach Neoplasms
Metaplasia
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pathologic Processes
Trametinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action