Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT00537095
Eligibility Criteria:
Inclusion Criteria:
* Previously confirmed histological diagnosis of locally advanced or metastatic papillary or follicular thyroid carcinoma, without anaplastic component. Tumor sample available for centralized exploratory analysis.
* Presence of one or more measurable lesions at least 1 cm in the longest diameter by spiral CT scan or 2 cm with conventional techniques.
* Progressive disease following RAI131 or patient unsuitable for RAI131 after surgery.
* Serum TSH \<0.5 mU/L.
Exclusion Criteria:
* Major surgery within 4 weeks before randomization.
* Prior chemotherapy within the last 4 weeks prior to randomization.
* RAI131 therapy within 3 months in patients with radioiodine uptake.
* Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy).
* Serum bilirubin \>1.5\*the upper limit of reference range (ULRR).
* Creatinine clearance \< 30 ml/min (calculated by Cockcroft-Gault formula).
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5\*ULRR, or greater than 5.0\*ULRR if judged by the investigator to be related to liver metastases.
* Clinically significant cardiovascular event (eg myocardial infarction), superior vena cava \[SVC\] syndrome, New York Heart Association \[NYHA\] classification of heart failure \>II within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
* History of arrhythmia (multifocal premature ventricular contractions \[PVCs\], bigeminy, trigeminy, ventricular tachycardia or uncontrolled atrial fibrillation), which is symptomatic or requires treatment (CTCAE grade 3), , or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication are permitted.
* Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00537095
Study Brief:
Protocol Section:
NCT00537095