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An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor RO5185426 in Patients with Metastatic or Unresectable Papillary Thyroid Cancer (PTC) Positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine (NO25530B)

Conditions

Metastatic Thyroid Cancer | Unresectable Papillary Thyroid Cancer

What is the purpose of this trial?

This research study designed to look at whether the drug vemurafenib (also called Zelboraf or RO5185426) can help stop the growth and spread of cancer cells in patients with papillary thyroid cancer (PTC) which has spread to other parts of the body (is metastatic), cannot be removed by surgery (is unresectable), and was or has become resistant to radioactive iodine treatments. The study will also collect additional information about the safety of Vemurafenib Vemurafenib is approved by the U.S. Food and Drug Administration (FDA) for the treatment of late stage melanoma whose tumors show a gene mutation called BRAF V600. It is not approved for treatment of PTC so in this study the use of Vemurafenib is investigational, meaning that it is not approved for routine treatment for PTC and can only be used in PTC in research studies such as this one. Secondary purposes of the study include • whether vemurafenib may be of benefit to patients previously treated with sorafenib who have PTC • pharmacokinetics of vemurafenib (to see how long the study drug stays in your body and how well your body can get rid of the drug) • if treatment with vemurafenib will have an effect on proteins in your blood, tumor or skin that will provide information on how your tumor responds to treatment. These proteins are called ‘biomarkers.’ You must allow testing of your samples for biomarkers for at least 5 years in order to participate in this study. Exploring biomarkers are an important part of this study because we are trying to identify what the right treatment is for different types of patients. • evaluate the Roche Companion Diagnostics (coDx) cobas® 4800 BRAF V6000 Mutation Test (to detect the BRAF gene mutation) from tumor samples. The 4800 BRAF is FDA approved for detecting the BRAF mutation in metastatic melanoma but is investigational in this study

Participation Guidelines

Age:
18 Years and older
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
Hoffmann-La Roche
Dates:
December 2011
Last Updated:
Study HIC#:
1111009271