Regorafenib for Thyroid Cancer

Not currently recruiting at 1 trial location

Overseen By Kartik Sehgal

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Regorafenib, Anticoagulants, Herbal remedies

Disqualifiers: Hypertension, Cardiac disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether regorafenib, a targeted therapy, can effectively treat thyroid cancer by attacking cancer cells while sparing normal ones. It specifically targets individuals with metastatic medullary thyroid cancer that has progressed within the last six months. Participants should have tried at least one other targeted therapy. For those with worsening thyroid cancer, this trial could be suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires stopping certain medications, like other anti-cancer therapies and some blood thinners, before starting the study drug. If you're on a medication like warfarin, you may need to switch to a low dose and be monitored closely. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that regorafenib is likely to be safe for humans?

Research has shown that regorafenib has been tested for safety in various conditions, including cancer. In one study involving 132 patients, regorafenib was generally well-tolerated, though some patients experienced side effects. A common issue was an increase in thyroid-stimulating hormone (TSH) levels, affecting about 31% of patients early in treatment.

The FDA has already approved regorafenib for other types of cancer, indicating it has passed several safety checks. However, every drug can cause side effects, and individuals may react differently. Prospective trial participants should discuss potential risks with the study team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for thyroid cancer?

Regorafenib is unique because it targets multiple pathways involved in thyroid cancer growth, setting it apart from standard treatments like surgery, radioactive iodine, and anti-thyroid drugs. This multi-kinase inhibitor works by blocking enzymes that promote tumor growth and blood vessel formation, potentially stopping cancer cells in their tracks. Researchers are excited because regorafenib’s ability to target these pathways could lead to more effective control of the disease, especially for patients who don't respond well to traditional therapies.

What evidence suggests that regorafenib might be an effective treatment for thyroid cancer?

Research suggests that regorafenib, administered to participants in this trial, might help treat thyroid cancer by targeting specific cancer cells. In earlier studies, 9% of patients experienced tumor shrinkage, and 40.9% had stable disease without progression. On average, patients lived without cancer progression for about 2.7 months and had an overall survival time of 10 months. Although information on using regorafenib for thyroid cancer is limited, its targeted approach shows promise. ^{1 3 6 7 8}

Who Is on the Research Team?

Kartik Seghal, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Adults with metastatic medullary thyroid cancer who've had at least one prior targeted therapy can join this study. They must be able to take oral meds, have a life expectancy of 3+ months, and agree to use contraception. Excluded are those with recent severe bleeding, certain infections like HIV or hepatitis B/C, uncontrolled high blood pressure, known allergies to the drug being tested (regorafenib), or other serious health issues.

Inclusion Criteria

I have previously received treatment specifically targeting my cancer.

My thyroid cancer has spread and was confirmed by a lab test.

I can provide a tissue sample from my cancer for testing.

Exclusion Criteria

Other investigational treatment during or within 30 days before starting study treatment.

I have a history of bleeding or clotting disorders.

I am experiencing mild to severe dehydration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive regorafenib tablets 80mg orally, once daily for 21 days per cycle

Up to 24 months

Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 and beyond Day 1

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 months

End of treatment and during follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Regorafenib

Trial Overview

The trial is testing regorafenib as a second or third line treatment for thyroid cancer. Regorafenib is a targeted therapy designed to attack cancer cells more precisely and spare normal cells. Participants will receive this medication orally to evaluate its effectiveness against their cancer.

How Is the Trial Designed?

Group I: Regorafenib Experimental Treatment 1 Intervention

Regorafenib tablets 80mg orally, once daily at predetermined dosage for 21 days per cycle

Regorafenib is already approved in United States, European Union for the following indications:

Approved in United States as Stivarga for:

• Metastatic colorectal cancer
• Gastrointestinal stromal tumors (GIST)
• Hepatocellular carcinoma (HCC)

Approved in European Union as Stivarga for:

• Metastatic colorectal cancer
• Gastrointestinal stromal tumors (GIST)
• Hepatocellular carcinoma (HCC)

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6872990/

Prolonged Response to Regorafenib in a Patient with Iodine ...

... thyroid cancer treated with regorafenib as part of a phase 1 clinical trial. ... The 5-year overall survival rates for localized thyroid cancer is 99.9 ...

2.

ar.iiarjournals.org

ar.iiarjournals.org/content/35/7/4059

Investigation of Regorafenib-induced Hypothyroidism in ...

During the first cycle of treatment with regorafenib, the incidence of abnormal thyroid-stimulating hormone (TSH) elevation was 31.4%. Our results suggest that ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10322943/

Association between thyroid function and regorafenib ...

Objective Response Rate was 9% and Disease Control Rate was 40.9%. Median PFS was 2.7 months (95%CI 2.2–3.6) and median OS was 10.0 months (95% ...

4.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2012/203085Orig1s000CrossR.pdf

203085Orig1s000 - accessdata.fda.gov

• Lack of exposure-response data from pivotal trial Bay 73-4506/14387,. • Lack of population pharmacokinetic analyses from Bay 73-4506/14387,.

5.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/51/NCT02657551/Prot_SAP_000.pdf

A phase II study of regorafenib in metastatic medullary and ...

There are no data about the activity of regorafenib in differentiated thyroid cancer (DTC). However, the biochemical properties of this drug ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2013/204369Orig1s000MedR.pdf

204369Orig1s000 - accessdata.fda.gov

The safety analysis was primarily based on the safety population of the GRID trial (132 patients treated with regorafenib and 66 treated on the placebo arm).

7.

researchgate.net

researchgate.net/publication/313962682_Phase_I_dose-escalation_study_of_continuously_administered_regorafenib_BAY_73-4506_an_inhibitor_of_oncogenic_and_angiogenic_kinases_in_patients_with_advanced_solid_tumors

Phase I dose-escalation study of continuously ...

The CORRECT trial demonstrated that regorafenib significantly increased OS, PFS, and DCR versus placebo in patients with chemorefractory mCRC, ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01339104

Open Label Regorafenib Study to Evaluate Cardiovascular ...

A phase I open-label trial evaluating the cardiovascular safety of regorafenib in patients with advanced cancer. Cancer Chemother Pharmacol. 2015 Oct;76(4): ...