Avutometinib + Defactinib for Stomach Cancer

Overseen By Research Nurse Navigator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ryan H. Moy, MD, PhD

Must not be taking: Warfarin, Strong CYP3A4, others

Disqualifiers: Brain metastases, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks per cycle

27 Participants Needed

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.

Research Team

Ryan Moy, MD, PhD

Principal Investigator

Columbia University

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.

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.

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

Treatment Details

Interventions

• Avutometinib
• Defactinib

Trial Overview 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.

Participant Groups

Group I: Avutometinib & Defactinib Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Ryan H. Moy, MD, PhD

Lead Sponsor

Trials

1

Recruited

30+

Verastem Oncology

Collaborator

Trials

2

Recruited

90+