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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

overall response rate (ORR) cohort A

overall response rate (ORR) cohort B

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

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,868 Total Patients Enrolled

Verastem, Inc.Industry Sponsor

38 Previous Clinical Trials

2,568 Total Patients Enrolled

Alan Ho, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

7 Previous Clinical Trials

247 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for the current iteration of this experiment?

"Clinicaltrials.gov confirms that this medical trial is still accepting participants, having been posted on August 16th 2023 and updated just one day later."

Answered by AI

To what extent is this trial being implemented in medical facilities?

"This clinical trial has 7 active sites, including Memorial Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown, Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale and Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities) in Commack. Additionally, there are several other locations involved."

Answered by AI

What risks may individuals with Radioiodine-refractory (RAIR), recurrent and/or metastatic differentiated thyroid cancer (DTC) face?

"According to our team at Power, Radioiodine-refractory (RAIR), recurrent and/or metastatic differentiated thyroid cancer (DTC) warrants a safety rating of 2 as it is currently undergoing Phase 2 trials. While there is evidence supporting its security, efficacy data has yet to be generated."

Answered by AI

How many volunteers are partaking in this experiment?

"Affirmative. According to the clinicaltrials.gov listing, this medical trial is currently open for enrolment and was most recently updated on August 17th 2023.. 30 patients are needed from 7 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Avutometinib and Defactinib in People With Thyroid Cancer

2023. "A Study of Avutometinib and Defactinib in People With Thyroid Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06007924.

All > Thyroid Cancer