Dabrafenib + Lapatinib for Thyroid Cancer

Overseen by Eric J Sherman

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing the combination of lapatinib and dabrafenib in patients with hard-to-treat thyroid cancer. The drugs work by blocking proteins that help cancer cells grow. The goal is to find the best dose and observe any anti-tumor activity. Dabrafenib has shown antitumor activity in various cancers, including thyroid cancer, and lapatinib is a tyrosine kinase inhibitor used in breast cancer treatment.

Research Team

Eric J Sherman

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for patients with thyroid cancer that's spread or can't be removed by surgery, and hasn't improved after standard treatments. Participants must have a specific BRAF V600E or V600K mutation in their tumor, good organ function, no recent cancer treatments, and an ability to swallow pills. Women who can have children need to use non-hormonal birth control during the study.

Inclusion Criteria

My PET scan shows a highly active lesion with an SUVmax of 3 or more.

I haven't had radioactive iodine therapy in the last 3 months.

My cancer does not absorb radioactive iodine well, as confirmed by a specialist.

Exclusion Criteria

Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments, their excipients, and/or DMSO

You cannot have taken any experimental drugs in the 28 days (or five half-lives, whichever is shorter, with a minimum of 14 days from the last dose) before starting the study and during the study.

Medical or psychiatric illness/social situations that would limit compliance with study requirements

Treatment Details

Interventions

• Dabrafenib (Protein Kinase Inhibitor)
• Lapatinib (Protein Kinase Inhibitor)

Trial Overview The trial is testing the combination of two drugs: Dabrafenib and Lapatinib. These drugs are believed to block enzymes important for cancer cell growth. The study aims to find the best dose with acceptable side effects for patients whose thyroid cancer has not been controlled by other treatments.

Participant Groups

Group I: Treatment (lapatinib, dabrafenib) Experimental Treatment 11 Interventions

Patients receive dabrafenib PO BID on days 1-28 of each cycle. After two weeks of single agent dabrafenib, patients also start receiving lapatinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo tumor biopsy, blood sample collection, ECHO or MUGA, as well as PET, CT, and/or MRI during screening and on study.

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

Approved in Canada as Tafinlar for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation
• Adjuvant treatment of melanoma with a BRAF V600 mutation

Approved in Japan as Tafinlar for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

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