Zanzalintinib for Thyroid Cancer

Overseen By Mark Zafereo, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Anticoagulants, Platelet inhibitors, Cytotoxics, others

Disqualifiers: RET mutations, Brain metastases, Uncontrolled hypertension, 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

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

45 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain medications like oral anticoagulants and some complementary medicines close to the start of the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Zanzalintinib for thyroid cancer?

Zanzalintinib is likely a kinase inhibitor, similar to other drugs like vandetanib and cabozantinib, which have shown promise in treating advanced thyroid cancers by targeting specific pathways involved in cancer growth. These types of drugs have been effective in clinical trials for thyroid cancer, suggesting that Zanzalintinib might also be beneficial. ^{1 2 3 4 5}

What safety data exists for Zanzalintinib in thyroid cancer treatment?

The safety of Zanzalintinib, like other tyrosine kinase inhibitors, may involve side effects that need careful management. While specific data on Zanzalintinib is not provided, similar drugs used in thyroid cancer treatment have shown manageable adverse effects, suggesting a need for monitoring during treatment. ^{1 6 7 8 9}

How is the drug Zanzalintinib unique for treating thyroid cancer?

Zanzalintinib is unique because it targets specific proteins involved in thyroid cancer growth, such as RET and VEGFR, which are not effectively addressed by conventional treatments. This makes it a promising option for patients with aggressive thyroid cancers that do not respond to standard therapies. ^{2 5 10 11 12}

What is the purpose of this trial?

To look at the effectiveness of zanzalintinib, followed by surgery, in treating advanced thyroid cancer. The safety of this treatment will also be studied.

Research Team

Mark Zafereo, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals with advanced thyroid cancer who are candidates for surgery. Specific eligibility criteria are not provided, but typically participants must be in good health aside from their thyroid condition and meet certain age and medical requirements.

Inclusion Criteria

I have advanced thyroid cancer without a specific genetic mutation.

My thyroid cancer diagnosis is confirmed by lab tests.

I have recovered from previous treatment side effects, or they are mild and under control.

Exclusion Criteria

My medullary thyroid cancer is caused by a specific genetic change.

My brain metastases have been treated and stable for at least 4 weeks.

I do not have any severe, uncontrolled health conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant zanzalintinib 100 mg orally once daily on Days 1 to 28 of a 28-day cycle

4 weeks

4 visits (in-person)

Surgery

Participants undergo surgical tumor resection after treatment with zanzalintinib

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment and surgery

48 weeks

Treatment Details

Interventions

• Zanzalintinib

Trial Overview The study is testing the effectiveness of a drug called Zanzalintinib as a pre-surgery (neoadjuvant) treatment for advanced thyroid cancer. The safety of this medication will also be evaluated during the trial.

Participant Groups

Group I: Neoadjuvant with Zanzalintinib Followed by Surgery Experimental Treatment 1 Intervention

Zanzalintinib 100 mg orally once daily on Days 1 to 28 of a 28-day cycle.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Exelixis

Industry Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Findings from Research

Thyroid carcinoma, particularly differentiated types, can often be treated effectively with surgery and radioactive iodine, but some aggressive forms like anaplastic and medullary thyroid carcinomas are resistant to current treatments, highlighting the need for new therapies.

Targeting specific genetic mutations, such as those in the RET proto-oncogene and B-RAF, offers promising avenues for new treatments, with drugs like ZD 6474 showing potential in preclinical models and ongoing trials for B-RAF inhibitors planned in thyroid cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New molecular targeted therapies in thyroid cancer. Milano, A., Chiofalo, MG., Basile, M., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Advanced thyroid cancers: new era of treatment. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Kinase inhibitors in thyroid cancers. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Multikinase inhibitors: a new option for the treatment of thyroid cancer. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Systemic treatment of advanced differentiated and medullary thyroid cancer. Overview and practical aspects. [2022]

5. England pubmed.ncbi.nlm.nih.gov

New molecular targeted therapies in thyroid cancer. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Target Therapy in Thyroid Cancer: Current Challenge in Clinical Use of Tyrosine Kinase Inhibitors and Management of Side Effects. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Targeted Therapy for Anaplastic Thyroid Carcinoma: Advances and Management. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Management of treatment-related toxicities in advanced medullary thyroid cancer. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Nursing Management and Adverse Events in Thyroid Cancer Treatments with Tyrosine Kinase Inhibitors. A Narrative Review. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Targeted therapy for thyroid cancer: An updated review of investigational agents. [2010]

11. United States pubmed.ncbi.nlm.nih.gov

Molecularly targeted therapies for thyroid cancers. [2021]

12. France pubmed.ncbi.nlm.nih.gov

Treatment of advanced thyroid cancer: role of molecularly targeted therapies. [2022]