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Tyrosine Kinase Inhibitor

Sunitinib for Thyroid Cancer

Phase 2
Waitlist Available
Led By Tanguy Y Seiwert
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients cannot have received prior receptor tyrosine kinase inhibitors or more than one prior chemotherapy regimen for metastatic disease
Patients must have histologically or cytologically confirmed papillary, follicular, or Hurthle cell carcinoma (cohort A) or medullary thyroid carcinoma (cohort B) with disease progression despite iodine-131 therapy or ineligibility for iodine-131 therapy and unresectable disease
Must not have
Conditions impairing ability to swallow and retain sunitinib tablets
Use of medications that are potent inducers or inhibitors of CYP3A4 liver enzyme
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Summary

This trial studies sunitinib malate for thyroid cancer that did not respond to iodine I 131. Sunitinib malate may stop cancer cell growth by blocking enzymes and blood flow to tumors.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Sunitinib may cause fatigue, nausea, high blood pressure, bleeding events or skin problems. There could also be risks of heart issues due to its effect on blocking blood flow which might affect other parts of the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't taken drugs for cancer that target enzymes or had more than one chemotherapy for my advanced cancer.
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I have a specific type of thyroid cancer that has worsened or can't be treated with surgery or iodine therapy.
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I can take care of myself and am up and about more than half of my waking hours.
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My heart condition is mildly symptomatic.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot swallow or keep down sunitinib tablets.
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I am taking strong medication that affects liver enzyme CYP3A4.
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I do not have brain metastases, serious illnesses, am not pregnant or breastfeeding, do not have HIV, and no specific heart conditions.
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My high blood pressure is not well-managed.
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I am taking warfarin or similar blood thinners.
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I am not currently on experimental drugs or have used drugs that stop the formation of blood vessels in tumors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST)
Secondary study objectives
Incidence of Toxicity, Graded According to the Common Terminology Criteria for Adverse Events Version 3.0
Overall Survival
Other study objectives
Changes in Laboratory Correlates Analyzed Using Paired T-tests

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (sunitinib malate)Experimental Treatment4 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sunitinib Malate
2008
Completed Phase 3
~3070
Sunitinib
2014
Completed Phase 3
~4380

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,937 Total Patients Enrolled
Tanguy Y SeiwertPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center

Media Library

Sunitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00381641 — Phase 2
Thyroid Cancer Research Study Groups: Treatment (sunitinib malate)
Thyroid Cancer Clinical Trial 2023: Sunitinib Highlights & Side Effects. Trial Name: NCT00381641 — Phase 2
Sunitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00381641 — Phase 2
~3 spots leftby Sep 2025
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