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Receptor Tyrosine Kinase Inhibitor

Targeted Therapy vs. Chemotherapy for Thyroid Cancer

Phase 3

Recruiting

Led By Lova Sun

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Congestive heart failure class 3 or 4 as defined by the New York Heart Association, unstable angina pectoris, or serious cardiac arrhythmias.

* Patient must be ≥ 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to radiographic progression of disease by response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares the effectiveness of cabozantinib versus a combination of dabrafenib and trametinib in treating patients with thyroid cancer that does not respond to treatment and has a specific

Who is the study for?

Adults with differentiated thyroid cancer that's unresponsive to treatment and has a BRAF V600E mutation. They must have tried or be ineligible for Iodine-131 therapy, taken certain tyrosine kinase inhibitors, and show measurable disease progression. Excludes those with severe heart issues or arrhythmias.

What is being tested?

The trial compares cabozantinib (a receptor tyrosine kinase inhibitor) against dabrafenib plus trametinib (both enzyme inhibitors) in treating refractory BRAF V600E-mutated thyroid cancer. It aims to determine which treatment is safer/more effective.

What are the potential side effects?

Potential side effects include fatigue, high blood pressure, hand-foot syndrome from cabozantinib; skin rash, fever, fatigue from dabrafenib; and rash, diarrhea, swelling from trametinib. Individual reactions may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have severe heart failure, unstable chest pain, or serious irregular heartbeats.

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I am 18 years old or older.

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I am able to get out of my bed or chair and move around.

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My thyroid cancer is a type of follicular carcinoma.

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I have been treated with lenvatinib or sorafenib for thyroid cancer.

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I have been treated with or am not eligible for Iodine-131 for thyroid cancer and am on thyroxine suppression therapy.

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My cancer has grown despite treatment, as shown by scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to radiographic progression of disease by response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to radiographic progression of disease by response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to radiographic progression of disease by response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, up to 5 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

Progression free survival (PFS)

Secondary study objectives

Duration of response

Incidence of adverse events

Objective response

+2 more

Other study objectives

Patient tolerability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (Cabozantinib)Experimental Treatment5 Interventions

Patients receive cabozantinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, blood sample collection and may undergo MRI throughout the study.

Group II: Arm A (Dabrafenib and trametinib)Active Control6 Interventions

Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, blood sample collection and may undergo MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Computed Tomography

2017

Completed Phase 2

~2790