Avutometinib and Defactinib in Diffuse Gastric Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRyan H. Moy, MD, PhD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Prior therapy with at least one line of therapy for unresectable/metastatic disease, which must include platinum and fluoropyrimidine.
ECOG performance status of 0 or 1
Age ≥ 18 years
Disqualifiers
Systemic anti-cancer therapy within 3 weeks of the first dose of study therapy, or within 5 half-lives of the previous drug, whichever is shorter.
Patients currently receiving any other investigational agent.
Subjects may not have had a history of malignancy other that esophagogastric cancer within two years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year overall survival >90%) such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer.
Major surgery within 4 weeks or palliative radiotherapy within 1 week of the first dose of study therapy.
Trial design
Design model
Single group
Treatments tested in this trial
Avutometinib
Drug3.2mg orally
Defactinib
Drug200 mg orally
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: Avutometinib & DefactinibExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
6 monthsSecondary outcomes
1
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.
Time frame
6 months2
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.
Time frame
24 months3
Median Overall Survival (OS)
Overall survival defined as the time from the start of treatment until death or last follow-up.
Time frame
Up to 5 years4
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.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov