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Study Purpose

Recent research into medullary thyroid cancer (MTC) is looking into new ways to treat the disease. The investigational treatment we are studying is a newer type of chemotherapy called targeted therapy. The aim of our study is to compare the safety and effectiveness of the investigational medication with that of the standard treatment for medullary thyroid cancer, which is traditional oral chemotherapy.

Physician with patient

Basic Details

CONDITION(s)

Medullary Thyroid Cancer

Approximate Enrollment Dates

Ongoing

Participants Required

400

Research Groups

Participants will be randomized into two study groups with a 2:1 ratio. This means that at the beginning of the study, volunteers have a 66% chance of receiving the study drug, and a 33% chance of receiving a standard therapy, either cabozantinib or vandetanib. Patients receiving cabozantinib or vandetanib may be eligible to receive the study drug later in the trial. Read more about this study’s treatment groups in the Frequently Asked Questions section below.

This study is not using a placebo.

Phase

Phase 3
Phase 3 research studies are the third step in a four-step drug approval process. In this phase, scientists test whether an investigational medication is more effective than the standard treatment in people with a specific disease or condition. Phase 3 studies often include around 300-3000 volunteers that have the disease or condition being studied.

Who Qualifies

You may qualify for this research study if you meet the criteria listed below. You can learn if you qualify after you indicate your interest in the study.

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Thyroid cancer that cannot be removed by surgery or has spread to other places in the body.

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No prior treatment with kinase inhibitors and evidence that the cancer has gotten bigger in the last 14 months.

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Evidence that your cancer is caused by a mutation in the RET gene.

Research Study Schedule

Approximate Appointment Timing

The first two months of study appointments are shown in the graphic. However, you can participate for as long as you and your doctor think you are benefitting from study participation.

2+ Months
10+ Appointments
2 Hours Average

Each appointment is a little different. For example, you may engage in any of these activities at a visit:

  • Laboratory tests (hematology, chemistry panel, pregnancy, etc.)
  • Vital statistics (weight, height, blood pressure, etc.)
  • Radiologic imaging
  • Patient dosing diary review or receipt
  • Investigational medication or comparator (cabozantinib or vandetanib) dosing

Locations

Researchers in over 100 sites globally are looking for volunteers for this research study.

Use the map or table below to find a participating site near you and call them for more information.

Research Site Name City State Phone Number

Next Steps

Step
One

Find a Research Site

Find a Research Site

Locate participating research sites in your area using the map or table in the Locations section above. Then choose your preferred research site. To use the map, select a pin to display the site contact information. To use the table, simply browse the results for contact information. You can also filter results using the search box if you’d like.

Step
Two

Connect with Research Site

Connect with Research Site

Call your preferred research site. The research site staff will tell you more about the research study, and answer any questions you may have. They will also ask you questions to assess your fit for the research study. If you are interested in the clinical trial, and seem eligible to participate, research study staff will schedule a time to further assess your fit for the research study.

Step
Three

Visit Research Site

Visit Research Site

During your appointment, the research study staff will continue to assess your fit for the study. They will also give you important research study information, like the schedule of appointments and the possible risks of participation. You will be able to ask questions too. This process of receiving important research study information is known as informed consent.

Step
Four

Participate in Research Study

Participate in Research Study

If you are eligible and want to participate, you can begin participating in the research study. To find out more about what’s involved in participation, review the Research Study Schedule. You can change your mind about being in the research study at any point. You don’t have to give a reason for leaving.

Frequently Asked Questions

No, this research study is not using a placebo.

(A placebo is not the investigational medication, but looks exactly like the investigational medication being studied.)

At the beginning of the study, you have a 100% chance of receiving an active medication.

Investigational
Medication
Cabozantinib or Vandetanib
(Standard of Care)
Study Population
(100%)
66% 33%

If you are in the group taking the standard of care, cabozantinib or vandetanib, you may begin receiving the investigational medication later in the study, depending on how you are doing.

Research studies are experimental in nature, so the risks and benefits can be difficult to predict. However, researchers only move forward with studies that they believe might be beneficial to the participant, with acceptable risks. You will have the opportunity to discuss risks and benefits in detail with the research site staff before agreeing to participate.

Possible Benefits

  • Access to a new treatment for medullary thyroid cancer before anyone else
  • Close monitoring, care, and support from a research team of doctors and other healthcare professionals who understand thyroid cancer
  • Play an active role in your healthcare
  • Could be part of the development of a new medication for thyroid cancer, possibly helping many others like you

Possible Risks

  • Your symptoms may not improve
  • Possibly receiving the standard of care (cabozantinib or vandetanib) instead of the investigational medication being studied
  • Side effects and / or adverse events
  • Substantial time commitments during the research study

Our study is designed to last a different length of time for each participant. This is to make sure that volunteers receive the safest, most effective dosage of the study drug or standard treatment, cabozantinib or vandetanib, for their specific needs. You can participate in the study as long as you like, as long as you and your study doctor think you are benefitting.

  • You have the right to drop out at any time.
    • You don’t have to give a reason.
  • You have the right to not participate in the research study.
    • Even if you’ve made it through screening and are “approved” to participate in the research study, you do not have to participate. If you decide to participate, you can still change your mind at any time, and leave the study. You don’t have to give a reason for leaving.
  • You have the right to be given more information about the study.
    • Informed consent is an ongoing process. You will be informed of any changes throughout the study.
  • You have the right to ask questions at any time.
    • You can ask questions about anything you don’t understand, or just want to know, at any time.

You do not have to take part in this study.

Your other choices may include:

  • Treatment or care for your thyroid cancer without being in a study.
  • No treatment.
  • Comfort care, also called supportive care. This type of care helps reduce pain, tiredness, appetite problems, and other problems caused by the cancer. It does not treat the cancer directly, but instead tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.
  • Participation in another clinical trial.

Are You Interested?

If you’re interested in participating in this research study, click the I’m Interested button. You will be taken to the Locations section where you can find a participating research site near you. You can use the site’s contact information to get in touch with someone at the research site for more information.

About Thyroid Cancer Research

Have you ever wondered how thyroid cancer medicines end up available to you and others with the disease? If you’re interested in learning more about thyroid cancer, we have an entire page devoted to thyroid cancer research and study participation.