Sunitinib for Thyroid Cancer

Recruiting at 17 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

63 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well sunitinib malate works in treating patients with thyroid cancer that did not respond to iodine I 131 (radioactive iodine) and cannot be removed by surgery. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Research Team

Tanguy Seiwert, M.D.

Principal Investigator

University of Chicago Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+