IRB Number:

07-004057

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

Patients are being asked to take part in this research study because they have metastatic medullary, anaplastic, or advanced differentiated thyroid carcinoma. This study is being done to learn what effects (good and bad) GW786034 has on the patient and their: metastatic medullary, anaplastic, or advanced differentiated thyroid carcinoma.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with metastatic medullary, anaplastic, or advanced differentiated thyroid cancer

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

If agreeing to be in the study, patients will be asked to participate in the following:

Treatment on this study will be given in periods of four weeks (or 28 days). Each 4-week period is known as a cycle. During each cycle patients will take GW786034 orally (by
mouth) daily. This schedule will be repeated every 28 days as long as the patient does not have serious side effects, their cancer does not get worse and the patient and their doctor agree that the patient should continue.

Patients will be asked to fill out a pill diary, instructed in its use, and asked to bring it with to each appointment. While taking GW786034, the patient will need to return to their study center each cycle to get the study drug and for examinations, blood tests, and/or scans or x-rays. The patient will have an EKG (electrocardiograms), which is a painless test involving an electrical measurement of the patient's heart. These tests are part of the routine care given to patients with cancer.

Patients will also need to check and record their blood pressure daily and keep track of this using a blood pressure diary, which the patient will need to bring with to each appointment. A blood pressure monitor will be provided to the patient free of charge for this study if needed.

Patients will also have blood drawn (approximately 2-3 tablespoons) weekly during the first cycle, and then at each appointment thereafter for research purposes. The patient will not be charged these blood tests as they are for research purposes only.

The drug used in this study is considered investigational, which means it has either not been approved by the U.S. Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA has allowed the use of this drug in this research study.

GW786034 (pazopanib), given as a pill, is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in this type of cancer. GW786034 (pazopanib) is an agent that inhibits angiogenesis which is new blood vessel formations and angiogenesis may be important in the development and progression of thyroid cancer. GW786034 (pazopanib) alters important regulators of new blood vessel formation important to the growth of some cancers. Therefore, GW786034 (pazopanib) is being specifically studied in thyroid cancer, because it has potential to
limit the growth of thyroid cancers, as they are believed to be dependent upon these mechanisms to continue to grow.

How long will the Study run?

Patients will be in the study for a maximum of three years.

Sponsor(s): Mayo Clinic

Study Activation/Registration Date: 02/22/2008

IRB Review and Approval Date: 02/14/2008

Study Type: Treatment

Projected Accrual: The plan is to enroll up to 108 patients to participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Keith C. Bible, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL

Last updated: 06/05/2008