Avutometinib + Defactinib for Stomach Cancer

Recruiting in Palo Alto (17 mi)

Overseen byRyan Moy, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Ryan H. Moy, MD, PhD

Must not be taking: Warfarin, Strong CYP3A4, others

Disqualifiers: Brain metastases, Hepatitis, HIV, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot take certain drugs that interact with the study medications, like strong CYP3A4, CYP2C9, P-glycoprotein, or breast cancer resistance protein inhibitors or inducers. If you're on warfarin, you may need to switch to a different blood thinner.

Eligibility Criteria

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.

Inclusion Criteria

I have recovered from previous cancer treatment side effects.

My disease's progress can be measured with scans.

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

+8 more

Exclusion Criteria

I do not have severe heart or lung conditions.

I am not taking any medications or supplements that could interfere with the study treatment.

Any other medical condition that in the opinion of the investigator would place the subject at unacceptably high risk for toxicity.

+14 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Avutometinib 3.2mg orally two times per week for three weeks followed by one week of rest, and Defactinib 200mg twice daily for three weeks followed by one week of rest

4 weeks per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

Up to 5 years

Participant Groups

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.

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