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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary outcome measures

Incidence of Toxicity, Graded According to the Common Terminology Criteria for Adverse Events Version 3.0

Overall Survival

Time to Progression or Death Evaluated Using the RECIST

Other outcome measures

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,090 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what medical scenarios is Sunitinib Malate typically employed?

"Sunitinib Malate is widely used to treat soft tissue sarcoma, but it can also be effectively utilized for treating gastrointestinal stromal tumors, metastatic pancreatic neuroendocrine tumors and advanced renal cell carcinoma."

Answered by AI

What possible adverse effects are associated with Sunitinib Malate utilization?

"Due to the fact that this is a Phase 2 trial, with some safety data but no efficacy evidence, Sunitinib Malate scored a 2 on our team's 1-3 scale."

Answered by AI

Are there other precedents for the use of Sunitinib Malate in clinical research?

"Sunitinib Malate was initially studied in 2006 at DuPage Medical Group - Joliet, with 808 trials completed thus far. At the moment, 34 of these clinical studies are actively recruiting patients, predominantly situated in Houston, Texas."

Answered by AI

What is the total number of healthcare facilities that are participating in this experimental research?

"This study is running out of 18 separate medical sites in places such as Houston, Saint Joseph and Peoria. To minimise transportation expenses when taking part, it's best to choose the nearest location available."

Answered by AI

How many individuals are actively participating in this clinical investigation?

"This clinical trial is no longer accepting new patients, with the initial posting on 8/8/2006 and its last update being 11/16/2022. If your search for a suitable study continues, there are currently 2681 trials recruiting individuals diagnosed with follicular thyroid carcinoma alongside 34 trials requiring Sunitinib Malate for their research."

Answered by AI

Are individuals currently able to enroll in this medical experiment?

"At the current time, this research project is not in need of any participants. It was initially posted on August 8th 2006 with its most recent update occuring November 16th 2022. For those looking for alternative studies, there are 2681 active trials seeking patients suffering from follicular thyroid carcinoma and 34 that require Sunitinib Malate volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery

2006. "Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00381641.

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