Status:
COMPLETED
Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Differentiated Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary Objective: To determine the efficacy (as assessed by progression-free survival \[PFS\]) of vandetanib when compared to placebo in participants with differentiated thyroid cancer that is eithe...
Detailed Description
Participants who received vandetanib as randomized treatment were allowed, upon re-consent, to continue on open-label vandetanib if in the opinion of the Investigator the participant received benefit....
Eligibility Criteria
Inclusion
- Provision of informed consent to participate in the study as well as provision of informed consent to provide a sample of a previously obtained archival tumor biopsy.
- Female or male aged 18 years and older with previously confirmed histological diagnosis of locally advanced or metastatic differentiated (excluding minimally invasive follicular) thyroid cancer not amenable to surgical resection, external beam radiotherapy or local therapy.
- Measurable disease defined as at least one lesion, not irradiated within 12 weeks of the date of randomization, that can be accurately measured at baseline.
- Participants must have experienced progression within 14 months and be RAI-refractory/resistant or unsuitable for RAI.
- Thyroid-stimulating hormone (TSH) suppression below 0.5 mU/L is required.
- World Health Organization (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
- Negative pregnancy test (urine or serum) for female participants of childbearing potential.
Exclusion
- Inadequate organ function as defined by: (1) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5\*upper limit of normal (ULN), or greater than 5.0\*ULN if judged by the Investigator to be related to liver metastases. (2) Serum bilirubin greater than 1.5\*ULN. This criterion does not apply to participants with known Gilbert's Disease. (3) Creatinine clearance \<50 mL/min (calculated by Cockcroft-Gault formula).
- Risk of prolonged interval between Q and T (QT) on an electrocardiogram (ECG) corrected for heart rate (QTc) as defined by: (1) Current therapy with any medication known to be associated with Torsades de pointes or potent inducers of cytochrome CYP3A4. (2) History of QT prolongation. (3) Congenital long QT syndrome. (4) QT interval corrected for heart rate by the Bazett's method (QTcB) correction unmeasurable or greater than 480 ms on screening ECG.
- Previous therapy with approved or investigational tyrosine kinase or anti- vascular endothelial growth factor (VEGF) receptor inhibitors or targeted therapies (e.g. multi-targeted kinase inhibitors such as sorafenib, AMG-706, sunitinib, pazopanib, lenvatinib).
- RAI therapy within 12 weeks prior to first dose of study drug, and radiation therapy other than RAI, including external beam, if not completed prior to randomization.
Key Trial Info
Start Date :
September 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2022
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT01876784
Start Date
September 17 2013
End Date
January 22 2022
Last Update
July 23 2024
Active Locations (61)
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1
Research Site
Little Rock, Arkansas, United States, 72205
2
Research Site
Torrance, California, United States, 90502
3
Research Site
Lexington, Kentucky, United States, 40536-0293
4
Research Site
Boston, Massachusetts, United States, 02114