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Kinase Inhibitor

Avutometinib + Defactinib for Stomach Cancer

Phase 2

Recruiting

Led By Ryan Moy, MD, PhD

Research Sponsored by Ryan H. Moy, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Concurrent congestive heart failure, prior history of class III/IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, unstable angina or severe obstructive pulmonary disease.

Inability to swallow oral medications.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using a combination of avutometinib and defactinib can help people with diffuse-type stomach cancer live longer, shrink their tumors, and do so safely.

Who is the study for?

This trial is for individuals with diffuse-type stomach cancer. Participants should not have had prior treatment for their condition and must be in a health state that allows them to undergo the study treatments.

What is being tested?

The trial is testing if taking avutometinib together with defactinib helps people live longer, shrinks tumors, and is safe for patients with diffuse gastric cancer.

What are the potential side effects?

Possible side effects of avutometinib and defactinib may include fatigue, nausea, diarrhea, decreased appetite, skin rash, and potential liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated with platinum and fluoropyrimidine for my advanced cancer.

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I am fully active or can carry out light work.

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I am 18 years old or older.

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My blood tests and heart function are within normal ranges.

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My heart's electrical cycle length is within a safe range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe heart or lung conditions.

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I cannot swallow pills.

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I am currently taking warfarin.

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I have been treated with drugs targeting FAK, MEK, or KRAS.

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I do not have active hepatitis B, C, or HIV requiring treatment.

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I have an eye condition.

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I haven't had major surgery in the last 4 weeks or palliative radiotherapy in the last week.

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I need medication or treatment for brain cancer symptoms.

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I have had rhabdomyolysis in the past.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS) Rate

Secondary study objectives

Disease Control Rate (DCR)

Duration of response (DOR)

Median Overall Survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Avutometinib & DefactinibExperimental Treatment2 Interventions

Avutometinib: Study participants will receive Avutometinib 3.2mg orally two times per week for three weeks in a row followed by one week of rest Defactinib: Study participants will receive Defactinib 200mg twice daily for three weeks in a row followed by one week of rest

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Defactinib

2013

Completed Phase 1

~60

0 / 15Eligibility criteria met