A Phase I Study of Dabrafenib plus Lapatinib to Treat Inoperable Thyroid Cancers with Abnormal BRAF

Protocol
13-061
Full Title
A Phase 1 Study of Dabrafenib in Combination with Lapatinib in BRAF Mutant Thyroid Cancer (NCI #9354)
Phase
I
Purpose

The purpose of this study is to evaluate the safety and preliminary effectiveness of dabrafenib and lapatinib in patients with inoperable thyroid cancers that contain an abnormal (mutated) form of BRAF and cannot be cured with radioactive iodine therapy.

Dabrafenib works by blocking the activity of abnormal BRAF. Lapatinib blocks two targets in cells that fuel cancer growth when mutated: EGFR and HER2. Earlier studies have suggested that targeting BRAF was not enough to treat thyroid cancer successfully because EGFR and HER2 became more active. It is hoped that treating the cancer with both drugs can overcome this resistance.

Dabrafenib is approved by the U.S. Food and Drug Administration for treating melanoma and lapatinib is approved for advanced breast cancer, but their use in treating thyroid cancer is considered investigational. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable thyroid cancer with a BRAF V600E mutation.
  • Patients’ cancers may not be curable using radioactive iodine, surgery, or external beam radiation therapy.
  • At least 3 months must have passed since prior radioactive iodine therapy and 4 weeks since any previous radiation therapy or chemotherapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eric Sherman at 646-888-4234.

Disease(s)
Thyroid Cancer
Locations
Related Diseases