A Phase II Trial of Avutometinib in Combination With Defactinib in Metastatic Diffuse Gastric Cancer
Ryan H. Moy, MD, PhD
Summary
The purpose of this study is to determine if the combination study treatment with avutometinib and defactinib will prolong life in participants, is effective in decreasing the size of the tumor(s), and if it is safe in subjects with diffuse-type stomach cancer.
Description
There are two main types of stomach cancer based on the appearance under the microscope: intestinal-type and diffuse-type. Some stomach cancers also have a mix of intestinal-type and diffuse-type (mixed type). The participants are being invited to take part in this research study due to having been diagnosed with stomach cancer that has spread to other parts of the body and/or cannot be surgically removed, has diffuse-type or mixed type cells or has gene changes that are associated with diffuse-type stomach cancers (such as mutations in the genes called CDH1 or RHOA), and have already been tre…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologic or cytologic evidence of gastric/gastroesophageal junction carcinoma, classified as diffuse type, poorly cohesive, signet ring cell, or mixed type. Patients with known pathogenic CDH1 and/or RHOA mutations will be allowed regardless of histology. 2. Prior therapy with at least one line of therapy for unresectable/metastatic disease, which must include platinum and fluoropyrimidine. 3. ECOG performance status of 0 or 1 4. Age ≥ 18 years 5. Adequate organ function, defined by the following laboratory parameters: a. Adequate hematologic function, including h…
Interventions
- DrugAvutometinib
3.2mg orally
- DrugDefactinib
200 mg orally
Location
- Columbia University Irving Medical CenterNew York, New York