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Kinase Inhibitor

Avutometinib + Defactinib for Thyroid Cancer

Phase 2
Recruiting
Led By Alan Ho, MD, PhD
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
Patients must have tissue from the primary tumor or metastases available for correlative studies
Age ≥ 18 years
Must not have
Treatment-refractory hypertension
Subjects with the inability to swallow oral medications or impaired gastrointestinal absorption
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if combining two drugs can effectively treat thyroid cancer with few side effects.

Who is the study for?
This trial is for adults with thyroid cancer that's not responding to radioiodine. Participants must have specific genetic changes in their tumors, measurable disease progression, and be able to take oral medication. They should have recovered from previous treatments and can't join if they've had certain recent surgeries or therapies, are pregnant/breastfeeding, or have severe heart issues, uncontrolled hypertension, active infections like COVID-19 within the last month.
What is being tested?
The study tests a combination of two drugs: Avutometinib and Defactinib on patients with RAF dimer-driven thyroid cancer who haven't responded well to radioiodine treatment. It aims to see if this drug combo is effective and safe with tolerable side effects.
What are the potential side effects?
While the trial seeks to determine the safety of Avutometinib and Defactinib, potential side effects may include mild or moderate reactions related to gastrointestinal health, cardiac function (like QT interval prolongation), liver enzymes elevation, fatigue or other common drug-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tissue samples from my cancer available for study.
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I am 18 years old or older.
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I can swallow pills without any major stomach or intestine problems.
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I am fully active or can carry out light work.
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My thyroid cancer has a specific genetic change confirmed by a certified lab.
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My heart's electrical cycle length is within a safe range.
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I have a specific type of thyroid cancer originating from follicular cells.
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I have anaplastic thyroid cancer.
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My heart pumps blood well, with an ejection fraction over 50%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My high blood pressure hasn't improved with treatment.
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I cannot swallow pills or have issues absorbing food/medicine.
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I have had rhabdomyolysis in the past.
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I have a history of glaucoma or issues with my retina.
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I do not have severe heart or lung conditions.
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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.
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I am currently taking warfarin.
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I have been treated with specific inhibitors before.
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I need medication or treatment for brain cancer symptoms.
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I am not taking any drugs that affect CYP3A4, CYP2C9, or P-gp.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
overall response rate (ORR) cohort A
overall response rate (ORR) cohort B

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Radioiodine-refractory (RAIR), recurrent and/or metastatic differentiated thyroid cancer (DTC)Experimental Treatment2 Interventions
Patients will be treated with avutometinib 3.2 mg twice weekly and defactinib 200 mg twice daily, both 3 weeks on/1 week off.
Group II: Anaplastic thyroid cancer (ATC)Experimental Treatment2 Interventions
Patients will be treated with avutometinib 3.2 mg twice weekly and defactinib 200 mg twice daily, both 3 weeks on/1 week off.
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?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,972 Previous Clinical Trials
597,698 Total Patients Enrolled
Verastem, Inc.Industry Sponsor
41 Previous Clinical Trials
2,805 Total Patients Enrolled
Alan Ho, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
7 Previous Clinical Trials
247 Total Patients Enrolled
~20 spots leftby Aug 2027
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