A Phase II Study of RO5185426 in Patients with Metastatic or Unresectable Papillary Thyroid Cancer Resistant to Radioactive Iodine

Protocol
11-115
Full Title
An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor Vemurafenib in Patients with Metastatic or Unresectable Papillary Thyroid Cancer (PTC) Positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine
Purpose

Many papillary thyroid cancers have mutations in a gene called BRAF. RO5185426 is an investigational drug that inhibits the altered BRAF protein produced by this mutated gene, thereby blocking the growth and spread of cancer cells.

In this study, researchers are evaluating the safety and effectiveness of RO5185426 in patients with metastatic or inoperable papillary thyroid cancer that persists despite standard treatment and radioactive iodine therapy. RO5185426 is a tablet taken orally (by mouth).

Investigator
Sherman, Eric, MD
Eligibility

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

  • Patients must have metastatic or inoperable papillary thyroid cancer that persists despite standard treatment and radioactive iodine therapy.
  • Patients’ tumors must contain the V600 mutation in the BRAF gene.
  • At least 4 weeks must have passed since completion of prior therapy 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.
  • Patients must be age 18 or older.

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

Disease(s)
Advanced Cancer
Thyroid Cancer