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Kinase Inhibitor
Avutometinib + Defactinib for Endometrial Cancer
Phase 2
Recruiting
Led By Rachel Grisham, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test a combination of drugs to treat advanced or recurrent gynecological cancer.
Who is the study for?
This trial is for women over 18 with advanced or recurrent mesonephric gynecologic cancer. They must have good kidney and liver function, no severe heart issues, and cannot be pregnant or breastfeeding. Prior treatment with certain inhibitors or a history of rhabdomyolysis excludes participation.Check my eligibility
What is being tested?
The study tests the effectiveness of Avutometinib (VS-6766) combined with Defactinib in treating mesonephric gynecologic cancers that are either persistent after first-line therapy or have returned after treatment.See study design
What are the potential side effects?
Potential side effects may include issues related to organ inflammation, vision changes like retinal pathology risks, increased blood pressure within the eye, gastrointestinal absorption problems if there's a history of surgeries affecting digestion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
best overall response
Secondary outcome measures
Incidence and severity of adverse events
Trial Design
1Treatment groups
Experimental Treatment
Group I: Avutometinib (VS-6766) and DefactinibExperimental Treatment2 Interventions
All enrolled patients will be treated with Avutometinib (VS-6766) 3.2 mg PO, twice weekly (e.g. M/Th,Tu/F, or W/Sa) + defactinib 200 mg PO BID for 3 weeks, followed by a 1 week rest period, in each 4-week (28 day) cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Defactinib
2013
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
Verastem, Inc.Industry Sponsor
38 Previous Clinical Trials
2,578 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,878 Total Patients Enrolled
20 Trials studying Endometrial Cancer
4,480 Patients Enrolled for Endometrial Cancer
Rachel Grisham, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
668 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is confirmed as GMC or has GMC characteristics according to my doctor.I cannot take pills by mouth or have issues absorbing food due to stomach surgery.My cancer has spread or returned after treatment.My heart pumps well, with an ejection fraction of 50% or higher.I haven't had major surgery in the last 4 weeks, minor surgery in the last 2 weeks, or palliative radiotherapy in the last week.I have been treated with a MEK, RAF, or FAK inhibitor before.I haven't had cancer treatment (except hormone therapy) recently.My heart's electrical activity is within a normal range, and I don't have a specific heart block.My liver, kidney, and blood functions are within normal ranges.I am on warfarin but can switch to another blood thinner if needed.I have eye conditions that could increase my risk for retinal vein occlusion.I am a woman aged 18 or older.I am currently pregnant or breastfeeding.I have another cancer, but it won't affect this trial's treatment.My brain scans after treatment show no worsening, or I have stable brain metastases not needing immediate treatment.I have a history of serious eye surface conditions.I am HIV positive, on treatment, and my viral load is undetectable.My side effects from previous treatments have mostly gone away or are mild.I have had rhabdomyolysis in the past.I have metastatic or recurrent disease and may or may not have had previous treatments.I agree to use effective birth control that is not hormonal during and for 1 month after the trial.I have another cancer, but it won't affect this trial's treatment.My hepatitis B virus load is undetectable with treatment.I had hepatitis C but am now cured, or I am being treated with an undetectable viral load.I am allergic to some ingredients in the trial medication.I haven't taken any medications or supplements in the last 14 days that could interfere with the study drugs.My cancer is not newly diagnosed, nor am I a candidate for surgery or radiation with a curative intent.
Research Study Groups:
This trial has the following groups:- Group 1: Avutometinib (VS-6766) and Defactinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled vacancies in this experiment for participants?
"The listing on clinicaltrials.gov reveals that the trial is currently welcoming patients to partake in it. It was opened for applications on March 15th 2023 and has been updated since then."
Answered by AI
Are VS-6766 and Defactinib viable treatments with minimal adverse effects?
"Our team at Power assigned VS-6766 and Defactinib a score of 2, considering the lack of evidence for efficacy but existing clinical data on safety."
Answered by AI
What is the upper limit for enrollment in this medical experiment?
"Affirmative. Details available on clinicaltrials.gov suggest that this investigation is currently recruiting, with the initial posting date being March 15th 2023 and the latest update following shortly after. The study aims to enrol 20 participants from 7 distinct trial sites."
Answered by AI
In what locations is this experiment being conducted?
"Currently, 7 different medical centres are recruiting for this trial. These sites include those located in Middletown, Montvale and Commack as well other cities that can be easily accessed to reduce the burden of travelling if you decide to join the study."
Answered by AI
Who else is applying?
What site did they apply to?
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
What portion of applicants met pre-screening criteria?
Met criteria
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