Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Objectives:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trametinib treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trametinib treatment | Drug | 1 mg taken by mouth once a day for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | About 12 months |
| Safety of Trametinib treatment: adverse events | Assessment of side effects induced during or after treatment with Trametinib. | About 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Primary registration
Secondary registration
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Goldenring, MD | Vanderbilt Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagasaki University Hospital | Nagasaki | Japan | ||||
| Nihon University School of Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D008679 | Metaplasia |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Endoscopy |
| Procedure |
A tiny camera on the end of a long, flexible tube will be used to examine the stomach and take biopsies. |
|
| Tokyo |
| Japan |
| University of Tokyo Medical Center | Tokyo | Japan |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 | Surgical Procedures, Operative |