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Kinase Inhibitor

Dabrafenib + Trametinib + IMRT for Thyroid Cancer

Phase 1
Recruiting
Led By Sasan Fazeli, MD
Research Sponsored by Manisha Shah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status < 2
Presence of BRAF mutation (V600E or V600K) in tumor tissue
Must not have
Known human immunodeficiency virus (HIV)-positive patients or those on combination antiretroviral therapy
Uncontrolled intercurrent illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether combining dabrafenib, trametinib, and intensity modulated radiation therapy (IMRT) is more effective at treating patients with BRAF mutated anaplastic thyroid cancer than just using IMRT alone.

Who is the study for?
This trial is for adults with anaplastic thyroid cancer that has a specific BRAF mutation. They should be in good physical condition (ECOG < 2), have certain blood cell counts within range, and not be pregnant or breastfeeding. Participants must agree to use contraception and cannot have had certain recent treatments or have overlapping radiation therapy fields from past treatments.
What is being tested?
The study tests the combination of two drugs, Dabrafenib and Trametinib, with intensity-modulated radiation therapy (IMRT) on patients with BRAF mutated anaplastic thyroid cancer. The goal is to see if this trio is more effective at stopping tumor growth than current methods.
What are the potential side effects?
Potential side effects include skin rash, fever, fatigue, nausea, liver enzyme changes indicating possible liver damage, high blood pressure, bleeding problems, heart issues like rapid heartbeat or heart failure signs. There may also be risks associated with radiation such as skin irritation or damage to nearby organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do all my daily activities without help.
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My tumor has a BRAF mutation (V600E or V600K).
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My diagnosis is anaplastic thyroid cancer.
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My kidney function, measured by creatinine, is within normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV-positive and/or on antiretroviral therapy.
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I do not have any unmanaged ongoing illnesses.
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I have been treated with a strong BRAF or MEK inhibitor before.
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I have brain metastases that are not under control.
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I am not on any medication that is not allowed in the study.
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I am currently being treated for another type of cancer.
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I have recovered from previous cancer treatment side effects, except for hair loss.
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My thyroid cancer is at an advanced stage but can still be removed with surgery.
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My heart condition limits my physical activity significantly.
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I have a history of specific eye conditions like RVO, CSR, or uncontrolled eye pressure.
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I've had radiation therapy to my neck or chest that overlapped areas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Objective response rate
Overall survival
Progression free survival
+1 more

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (dabrafenib, trametinib, IMRT)Experimental Treatment3 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1630
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2060
Dabrafenib
2011
Completed Phase 3
~4120

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,023 Total Patients Enrolled
Manisha ShahLead Sponsor
2 Previous Clinical Trials
76 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,574 Total Patients Enrolled

Media Library

Dabrafenib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03975231 — Phase 1
~1 spots leftby Oct 2025
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