Active not recruitingPHASE3INTERVENTIONAL

A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

This research is looking at how effective a drug called cabozantinib is for people with a type of thyroid cancer called differentiated thyroid cancer. This is for patients whose cancer has grown even after previous treatments, specifically those targeting blood vessel growth (VEGFR-targeted therapies). The study will compare cabozantinib against a placebo (a dummy drug) to see if it can stop the cancer from getting worse for longer and if it can shrink the tumours. It's a late-stage trial, meaning the drug has already undergone earlier testing. The goal is to find new ways to help patients when their current treatments are no longer working as well as hoped.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Exelixis

Enrolment target

187

Start

05 Oct 2018

Estimated completion

31 Jul 2026

Differentiated Thyroid Cancer

Results

Results from this study

Posted May 2023

Results have been published for this study.

Primary outcome

Progression Free Survival (PFS)

Time to the earlier of either radiographic progressive disease (PD) or death from any cause.

Full results on the registry

What is this study about?

This clinical trial is investigating a new treatment option for a specific type of thyroid cancer called differentiated thyroid cancer (DTC). This particular study focuses on patients whose cancer has unfortunately continued to grow despite having tried other treatments, specifically those medicines designed to block the growth of new blood vessels that feed the cancer (what doctors call VEGF receptor-targeted therapies). The main aim is to see if a drug called cabozantinib can help slow down or stop the cancer from getting worse for a longer period compared to a dummy drug (placebo).

When a cancer "progresses," it means it's growing or spreading. So, the researchers are looking at how long patients live without their cancer getting worse, which they call "progression-free survival." They also want to see if the drug can shrink the tumours, known as "objective response rate." This is a 'Phase 3' study, which is typically the final stage of testing before a new treatment might be considered for wider use, if it's proven to be safe and effective.

It's important for scientists to keep looking for new and better treatments, especially for patients whose cancer is proving difficult to manage with existing options. This study hopes to provide valuable information that could lead to another treatment choice for people living with advanced differentiated thyroid cancer.

Key takeaways

Investigates a new drug (cabozantinib) for advanced thyroid cancer.
For patients whose cancer has grown after other targeted treatments.
Compares cabozantinib to a dummy drug (placebo).
Aims to slow cancer progression and potentially shrink tumours.
Participation involves regular check-ups, tests, and scans.
It's a Phase 3 trial, a late stage of drug development.

Who may be eligible?

To be considered for this study, you would need to have a confirmed diagnosis of differentiated thyroid cancer. This means doctors have looked at your tissue samples and confirmed the specific type of cancer. Your cancer would also need to be measurable, meaning doctors can accurately track its size and changes during the study. You must have received previous treatment for your thyroid cancer, possibly including radioactive iodine-131, or your doctors decided it wasn't suitable for you. Additionally, you would have already tried at least one, but no more than two, specific types of targeted therapies for your thyroid cancer, such as lenvatinib or sorafenib, and your cancer has unfortunately progressed.

There are also some reasons why you wouldn't be able to join. For example, if you've already had cabozantinib or certain other specific cancer treatments like more than two blood vessel-targeting drugs, or certain types of chemotherapy or immunotherapy. There are also time limits after receiving certain treatments or radiation therapy before you could join the study. If your cancer has spread to your brain or you have certain other serious medical conditions, you might also not be able to take part. The study team would carefully check all your medical history to see if it's right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a confirmed diagnosis of differentiated thyroid cancer?
Has your cancer continued to grow despite previous treatments for blood vessel growth (VEGFR-targeted therapies)?
Have you not previously taken the study drug, cabozantinib?
Are you generally well and active enough for daily tasks?
Could you attend regular hospital visits for check-ups and tests?
Are you aged 16 or over?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the study drug, cabozantinib, or a placebo (a dummy pill that looks like the study drug but contains no active medicine). This is done by chance, like flipping a coin, so neither you nor your doctor can choose which one you receive.

You would need to attend regular clinic visits for check-ups, blood tests, and scans to monitor your health and the cancer's response. These visits would help the doctors understand how well the treatment is working and if there are any side effects. You'd continue with the treatment and visits for as long as it's helping you and you're not experiencing significant side effects, or until the study doctors decide it's no longer the best option. The total duration of your participation would depend on how your cancer responds to the treatment.

Potential risks and benefits

Participating in a clinical trial might offer potential benefits, such as access to a new treatment before it's widely available, and close monitoring of your health by a medical team. However, there are also potential risks; the study drug might cause side effects, some of which could be serious, and it may not work for everyone. The placebo, being an inactive substance, comes with no drug-related side effects but also no potential therapeutic benefits. You have the right to withdraw from the study at any time, for any reason, without affecting your current or future medical care.

Locations (164)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Exelixis Clinical Site #2
Verified postcode
Newport Beach, United States
Exelixis Clinical Site #98
Verified postcode
Sacramento, United States
Exelixis Clinical Site #69
Verified postcode
San Francisco, United States
Exelixis Clinical Site #10
Verified postcode
Stanford, United States
Exelixis Clinical Site #3
Verified postcode
Torrance, United States
Exelixis Clinical Site #9
Verified postcode
Aurora, United States
Exelixis Clinical Site #21
Verified postcode
New Haven, United States
Exelixis Clinical Site #4
Verified postcode
Washington D.C., United States
Exelixis Clinical Site #94
Verified postcode
Miami, United States
Exelixis Clinical Site #93
Verified postcode
Orlando, United States
Exelixis Clinical Site #6
Verified postcode
Tampa, United States
Exelixis Clinical Site #164
Verified postcode
Chicago, United States

Common questions

What is 'differentiated thyroid cancer'?

It's a common type of thyroid cancer that usually responds well to standard treatments, but sometimes it can be more challenging to treat if it doesn't respond to radioactive iodine.

What is 'radioiodine-refractory'?

This means the cancer has not responded to treatment with radioactive iodine (I-131), which is a common and effective treatment for many thyroid cancers.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the actual study drug but contains no active medicine. It helps researchers compare the effects of the real drug.

What are 'VEGFR-targeted therapies'?

These are specific drugs that work by blocking signals that help new blood vessels grow to feed cancer cells. They are a type of targeted cancer treatment.

Why is this study needed?

This study aims to find new treatment options for patients whose differentiated thyroid cancer has continued to grow despite trying existing targeted therapies.