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MEK Inhibitor
Trametinib for Thyroid Cancer
Phase 2
Waitlist Available
Led By Alan L Ho
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial studies the effectiveness of trametinib in increasing iodine uptake in patients with thyroid cancer that has returned or spread. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may help make treatment with iodine I-131 more effective.
Who is the study for?
This trial is for adults with recurrent or metastatic thyroid cancer who have measurable disease, adequate organ function, and a life expectancy over 3 months. They must not be pregnant, agree to use contraception, and be willing to undergo biopsies. Exclusions include other recent cancers (with some exceptions), lung disease, certain heart risks, active infections or severe psychiatric issues.
What is being tested?
The study tests trametinib's ability to enhance iodine incorporation into tumors in thyroid cancer patients. This could make iodine I-131 treatment more effective. Participants will receive trametinib and undergo imaging studies like CT scans and PET scans along with laboratory biomarker analysis.
What are the potential side effects?
Trametinib may cause side effects such as skin rash, diarrhea, fatigue, nausea and swelling of the face or limbs. It can also increase blood pressure and affect heart function which will be monitored during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Iodine Incorporation in Thyroid Cancer Metastases to a Predicted Lesional Absorbed Radiation Dose Equal to or Exceeding 2,000 cGy With the Administration of =< 300 mCi Radioiodine (RAI) (Cohort B)
Percentage With Objective Response (Complete Response or Partial Response) (Cohort A)
Percentage of Patients Progression Free at 6 Months Following Treatment With Trametinib and I-124 (Cohort A)
+1 moreSecondary study objectives
Adequate Increase in Iodine Corporation (Cohort A)
Change in Thyroglobulin (Cohort B)
Changes in Thyroglobulin
+4 moreOther study objectives
Expression and Phosphorylation of MAPK Signaling Pathway Proteins
Expression and Phosphorylation of Negative Feedback Loops Connected to the MAPK Pathway (Such as Human Epidermal Growth Factor 3)
Presence of Other Genetic Alterations
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort C (trametinib)Experimental Treatment3 Interventions
Patients may continue trametinib at the doctor's discretion and do not receive iodine I-131.
Group II: Cohort B (iodine I-124 PET/CT, trametinib, iodine I-131)Experimental Treatment7 Interventions
Patients without BRAF/RAS gene mutations undergo iodine I-124 PET/CT on day 5 of week 1. Beginning day 6, patients receive trametinib PO daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo second iodine I-124 PET/CT on week 5. If I-124 PET/CT shows enough iodine absorption, patients may receive iodine I-131 PO and continue receiving trametinib for another 2 days. If I-124 shows that the thyroid is not absorbing iodine, patients have the option to be assigned to Cohort C.
Group III: Cohort A (iodine I-124 PET/CT, trametinib, iodine I-131)Experimental Treatment7 Interventions
Patients with RAS gene mutations undergo iodine I-124 PET/CT on day 5 of week 1. Beginning day 6, patients receive trametinib PO daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo second iodine I-124 PET/CT on week 5. If I-124 PET/CT shows enough iodine absorption, patients may receive iodine I-131 PO and continue receiving trametinib for another 2 days. If I-124 shows that the thyroid is not absorbing iodine, patients have the option to be assigned to Cohort C.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Positron Emission Tomography
2011
Completed Phase 2
~2200
Trametinib
2014
Completed Phase 2
~1630
Iodine I-131
2015
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,925 Previous Clinical Trials
41,017,967 Total Patients Enrolled
9 Trials studying Thyroid Gland Carcinoma
12,033 Patients Enrolled for Thyroid Gland Carcinoma
Alan L HoPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain or spinal cord cancer symptoms that are not treated.I have a history of heart problems.I have specific eye conditions.I cannot follow a low iodine diet or need medication high in iodide.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My thyroid cancer has been confirmed and is of follicular origin.I am not pregnant or nursing, as the study drug may be unsafe.I am not currently using any medications that are not allowed in the study.You have had a bad reaction to drugs similar to trametinib or to certain other substances.I can take care of myself but might not be able to do heavy physical work.I haven't taken any experimental drugs in the last 28 days or more.I have had interstitial lung disease or pneumonitis.I've been cancer-free for 3 years, or had non-melanoma skin cancer removed, or have a slow-growing secondary cancer.I do not have active HIV, HBV, or HCV, or I have chronic/cleared HBV or HCV.I've had a dye injection for a scan within the last 3 months but may still qualify if tests show the dye is cleared from my body.Your disease does not respond to radioactive iodine treatment, as shown in imaging tests.I haven't had recent thyroid cancer treatment.You are expected to live for more than 3 months.All my side effects from previous treatments are mild, except for hair loss.Your body has enough infection-fighting white blood cells.Your hemoglobin level is at least 9 grams per deciliter.I agree to use birth control during and 4 months after the study, and I am not pregnant.My cancer has a specific mutation in NRAS, KRAS, or HRAS.Your AST and ALT levels are not more than 2.5 times the normal limit at the hospital where you are being treated.My kidney function is normal, based on creatinine levels or clearance.Your heart's pumping function is within the normal range based on specific heart tests.My cancer is BRAF/RAS wild type.I can provide tissue samples from my thyroid cancer for the study.My cancer has worsened or spread in the last 14 months.My thyroid tumor lacks certain genetic mutations.My thyroid tumor has a specific mutation (NRAS, KRAS, or HRAS).You must have a platelet count of at least 100 billion per liter.I have a tumor that can be measured and has grown after radiation.Your albumin level in the blood is at least 2.5 grams per deciliter.I am not HIV-positive or not on antiretroviral therapy.Your total bilirubin level is within a certain range considered normal at the hospital.Your blood clotting time is within the normal range.I agree to have two biopsies unless certain conditions apply.I can take pills and don't have major stomach or bowel issues affecting drug absorption.My cancer has a BRAF V600 mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A (iodine I-124 PET/CT, trametinib, iodine I-131)
- Group 2: Cohort B (iodine I-124 PET/CT, trametinib, iodine I-131)
- Group 3: Cohort C (trametinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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