Trametinib for Thyroid Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Alan L Ho, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well trametinib works in increasing tumoral iodine incorporation in patients with thyroid cancer that has come back or spread to another place in the body. 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.

Research Team

Alan L Ho, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

My thyroid cancer has been confirmed and is of follicular origin.

I can take care of myself but might not be able to do heavy physical work.

Your disease does not respond to radioactive iodine treatment, as shown in imaging tests.

Exclusion 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.

Treatment Details

Interventions

• Trametinib (MEK Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Cohort C (trametinib) Experimental Treatment 3 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 Treatment 7 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 Treatment 7 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.

Trametinib is already approved in Canada, Japan for the following indications:

Approved in Canada as Mekinist for:

• Melanoma
• Non-small cell lung cancer

Approved in Japan as Mekinist for:

• Melanoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School