Clinical Trials /

Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor

NCT04454476

Description:

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.

Related Conditions:
  • Gastric Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor
  • Official Title: Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor Treatment

Clinical Trial IDs

  • ORG STUDY ID: VICC GI 2049
  • NCT ID: NCT04454476

Conditions

  • Gastric Cancer
  • Metaplasia
  • Stage I Gastric Cancer
  • Initial-onset Gastric Cancer

Interventions

DrugSynonymsArms
Trametinib treatmentTrametinib treatment

Purpose

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
    

Trial Arms

NameTypeDescriptionInterventions
Trametinib treatmentExperimental
  • Trametinib treatment

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Effectiveness of Trametinib in reversing metaplasia: changes in cell lineages
Time Frame:About 12 months
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Vanderbilt-Ingram Cancer Center

Last Updated

June 30, 2020