Sunitinib for Thyroid Cancer

No longer recruiting at 18 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must be taking: Thyroxine

Must not be taking: Antiangiogenics, Anticonvulsants, Antiretrovirals, others

Disqualifiers: Hypertension, Heart failure, Brain metastases, 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: Unknown

Duration: 6 weeks per cycle

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how effectively sunitinib malate, a type of cancer treatment, can treat thyroid cancer that hasn't responded to radioactive iodine treatment and can't be surgically removed. The goal is to determine if sunitinib can slow or stop tumor growth by blocking certain enzymes and blood flow to the tumor. This trial suits individuals with specific types of thyroid cancer who have experienced disease progression despite other treatments and cannot undergo surgery to remove their tumors. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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

The trial does not specify if you must stop all current medications, but you cannot take certain medications that affect the liver enzyme CYP3A4. If you're on such medications, the trial team will review your case to see if you can switch to other drugs.

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

Research has shown that sunitinib malate is usually well-tolerated by patients, though some side effects may occur. One study found that nine patients required dose adjustments due to side effects, indicating that the treatment can be modified for better tolerance. Sunitinib has been used for other conditions, providing some confidence in its safety. However, as with any treatment, unwanted effects may arise, so close monitoring remains crucial. Prospective participants should discuss potential risks and benefits with a healthcare provider before joining a trial. ^{1 2 3 4 5}

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

Sunitinib is unique because it targets multiple pathways involved in tumor growth and blood vessel formation, unlike standard treatments for thyroid cancer, which often focus on a single pathway. This multi-targeted approach can potentially make sunitinib effective against tumors that are resistant to other therapies. Researchers are excited about sunitinib because it offers a promising option for patients with advanced thyroid cancer, especially those who haven't responded well to existing treatments like surgery, radioactive iodine, or other tyrosine kinase inhibitors.

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

Research has shown that sunitinib malate, the treatment under study in this trial, holds promise for treating certain thyroid cancers. In earlier studies, approximately 50% of patients with medullary thyroid cancer experienced tumor shrinkage. Another study found that about 33% of patients saw their tumors shrink, offering hope for those whose thyroid cancer does not respond to standard treatments. Sunitinib blocks enzymes that cancer cells need to grow and cuts off the tumor's blood supply. This two-pronged approach helps slow down or shrink the cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Tanguy Seiwert, M.D.

Principal Investigator

University of Chicago Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with thyroid cancer that's resistant to radioactive iodine treatment and can't be surgically removed. They should have measurable disease, no prior similar treatments, a healthy heart rhythm, and agree to use contraception. They must understand the study and consent to participate, expect to live more than 12 weeks, have an ECOG status of 0-2 (able to perform daily activities), meet specific blood count criteria, and show recent disease progression.

Inclusion Criteria

My condition has worsened in the past 6 months.

I haven't taken drugs for cancer that target enzymes or had more than one chemotherapy for my advanced cancer.

Your blood needs to have certain levels of different components.

Exclusion Criteria

I cannot swallow or keep down sunitinib tablets.

I am taking strong medication that affects liver enzyme CYP3A4.

My high blood pressure is not well-managed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sunitinib malate orally once daily on days 1-28. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

6 weeks per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up periodically for up to 2 years.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Sunitinib
• Sunitinib Malate

Trial Overview The trial tests Sunitinib Malate's effectiveness on thyroid cancers unresponsive to iodine I 131. It examines if this drug can halt tumor growth by inhibiting necessary enzymes for cell proliferation and cutting off the tumor’s blood supply.

How Is the Trial Designed?

Group I: Treatment (sunitinib malate) Experimental Treatment 4 Interventions

Patients receive sunitinib malate PO QD on days 1-28. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity

Sunitinib is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Sutent for:

• Renal Cell Carcinoma
• Gastrointestinal Stromal Tumor

Approved in European Union as Sutent for:

• Renal Cell Carcinoma
• Gastrointestinal Stromal Tumor
• Pancreatic Neuroendocrine Tumors

Approved in Canada as Sutent for:

• Renal Cell Carcinoma
• Gastrointestinal Stromal Tumor

Approved in Japan as Sutent for:

• Renal Cell Carcinoma
• Gastrointestinal Stromal Tumor

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3227944/

Efficacy of Sunitinib in Advanced Medullary Thyroid ... Nine patients had to have their doses of sunitinib reduced. Two patients had a confirmed partial response, three had an unconfirmed partial response (33.3%), ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00381641?cond=%22Medullary%20Thyroid%20Carcinoma%22&intr=%22angiogenesis%20inhibitors%22&viewType=Table&rank=3

Study Details | Sunitinib Malate in Treating Patients With Thyroid ... Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3063514/

Phase II Study of Daily Sunitinib in FDG-PET Positive, ... Although we reported results from both cancers combined, the RECIST response rates were similar (WDTC = 28%; MTC = 50%), and sunitinib clearly had activity in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00510640

Study Details | NCT00510640 | Thyroid Cancer and Sunitinib The objective of the trial is to determine the objective tumor response rate (efficacy) in patients with locally advanced or metastatic anaplastic, ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)34437-0/fulltext

Could thyroid dysfunction influence outcome in sunitinib ... Sunitinib is a standard of care for metastatic renal cell carcinoma (mRCC). Hypothyroidism is frequently observed under sunitinib therapy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5943825/

Benefit, Risk, and Outcomes in Drug Development In total, 1052 patients in sunitinib monotherapy experienced objective tumor response (15.7% of intent-to-treat population, 95% confidence ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1526820921001373

Clinical Breast Cancer Herein, we report outcomes regarding safety and efficacy of daily sunitinib in combination with weekly paclitaxel followed by weekly doxorubicin and daily ...

8. sutent.pfizerpro.com sutent.pfizerpro.com/efficacy/advanced-rcc/primary-endpoint

Efficacy | SUTENT® (sunitinib malate) for HCP | Safety Info Primary endpoint: progression-free survival (PFS) · SUTENT demonstrated 11-month median PFS · Study description · 94% of patients in the pivotal trial were ...