Avutometinib and Defactinib in Diffuse Gastric Cancer
NCT Number: NCT06487221
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gastric Cancer|Stomach Cancer
Interventions: DRUG: Avutometinib|DRUG: Defactinib
Sponsor: Ryan H. Moy, MD, PhD
Collaborators: Verastem Oncology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2029-05-30
Locations: Columbia University Irving Medical Center, New York, New York, 10032, United States

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.

Primary Outcome Measures: Progression-free survival (PFS) Rate, To determine the efficacy of combination defactinib and avutometinib in patients with metastatic diffuse gastric cancer (DGC) as measured by 6-month progression-free survival (PFS) rate. PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first., 6 months
Secondary Outcome Measures: Overall Response Rate (ORR), Overall response rate (ORR) defined as partial response (PR) + complete response (CR) according to Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\]. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR is a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm., 6 months|Median Progression-Free Survival, To determine the impact of combination defactinib and avutometinib on other measures of efficacy off progression free survival (PFS). Time from the start of treatment until disease progression or death, whichever comes first., 24 months|Median Overall Survival (OS), Overall survival defined as the time from the start of treatment until death or last follow-up., Up to 5 years|Disease Control Rate (DCR), DCR defined as Complete Response (CR)+ Progressive Disease (PD)+ Stable Disease (SD) as assessed per RECISIT 1. CR is a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study., 24 months|Duration of response (DOR), The duration of overall response is measured from the time measurement criteria are met for CR (Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm) or PR (At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), whichever is first recorded, until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started)., 24 months