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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of combination therapy of dabrafenib and trametinib administered concurrently with intensity-modulated radiation therapy (IMRT)
Secondary outcome measures
Objective response rate
Overall survival
Progression free survival
+1 moreTrial 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
~1550
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Dabrafenib
2011
Completed Phase 3
~4120
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,759 Total Patients Enrolled
Manisha ShahLead Sponsor
2 Previous Clinical Trials
76 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,654 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV-positive and/or on antiretroviral therapy.I do not have any unmanaged ongoing illnesses.I have been treated with a strong BRAF or MEK inhibitor before.I can do all my daily activities without help.I haven't taken any oral cancer drugs in the last week.I have brain metastases that are not under control.I am not on any medication that is not allowed in the study.My tumor has a BRAF mutation (V600E or V600K).I am currently being treated for another type of cancer.Your total bilirubin level should be within a certain range, unless you have a condition called Gilbert's disease.I have recovered from previous cancer treatment side effects, except for hair loss.My thyroid cancer is at an advanced stage but can still be removed with surgery.My heart condition limits my physical activity significantly.Your platelet count is higher than 75,000 per microliter.You have enough infection-fighting white blood cells in your body.Your liver enzymes (AST/ALT) are less than 2.5 times the normal limit.Your heart's QT interval is longer than 480 milliseconds (500 milliseconds if you have Bundle Branch Block).I agree to use effective birth control.I have a history of specific eye conditions like RVO, CSR, or uncontrolled eye pressure.I've had radiation therapy to my neck or chest that overlapped areas.Your hemoglobin level is 9.0 grams per deciliter or higher.My diagnosis is anaplastic thyroid cancer.I haven't had chemotherapy or certain types of radiation in the last 2 weeks.My kidney function, measured by creatinine, is within normal range.I am a woman who can have children and have a recent negative pregnancy test.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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