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Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment

A Randomized,Int.,Open-Label Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients With Locally Advanced or Metastatic MTC Experience Grade 2 or Higher AEs in the First 12 Months of Treatment With Vandetanib

NCT01298323•Sanofi

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of informed consent prior to any study specific procedures
•Female or male aged 18 years and over
•Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Documentation must be provided in patient's medical chart
•WHO or ECOG Performance status 0-2
•Negative pregnancy test (urine or serum) for female patients of childbearing potential

Exclusion Criteria

•Unstable brain metastases or spinal cord compression that require treatment, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
•Major surgery within 4 weeks before randomization
•The last dose of prior chemotherapy received less than 3 weeks prior to randomization
•Radiation therapy not completed prior to the first dose of vandetanib
•Significant cardiac event, superior vena cava syndrome, NYHA classification of heart disease ≥2, within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases risk of ventricular arrhythmia
•Creatinine clearance \<30 ml/min (calculated by Cockcroft-Gault formula),Patients with moderate renal impairment, defined as creatinine clearance ≥30 to \<50 ml/min, must start vandetanib at a reduced dose of 200 mg

Locations (66)

Investigational Site Number : 301

St Leonards, New South Wales, Australia

Investigational Site Number 301

St Leonards, Australia

Investigational Site Number 401

Vienna, Austria

Investigational Site Number : 401

Vienna, Austria

Investigational Site Number : 501

Anderlecht, Belgium

Investigational Site Number 501

Brussels, Belgium

Hospital De Clinicas De Porto Alegre Site Number : 701

Porto Alegre, Rio Grande do Sul, Brazil

Faculdade de Medicina de Ribeirao Preto - USP Site Number : 702

Ribeirão Preto, São Paulo, Brazil

Investigational Site Number 701

Porto Alegre, Brazil

Investigational Site Number 702

Ribeirão Preto, Brazil

Key Dates

Start Date

February 25, 2011

Primary Completion Date

April 26, 2013

Completion Date

March 13, 2025

Last Updated

April 24, 2025

Enrollment

205

ACTUAL participants

Conditions

Locally Advanced or Metastatic Medullary Thyroid CancerMedullary Thyroid Cancer

Interventions

Patient outreach

BEHAVIORAL

Vandetanib

DRUG

Natural History Study of Children and Adults With Medullary Thyroid Cancer

NCT01660984

Medullary Thyroid Cancer

View study

RECRUITINGPHASE1/PHASE2

Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors

NCT06814496

MelanomaMedullary Thyroid Cancer+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment

Inclusion Criteria

Exclusion Criteria

Natural History Study of Children and Adults With Medullary Thyroid Cancer

Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors

Evaluation of the 18F-PSMA Positron Emission Tomography (PET)/CT in Patients With Medullary Thyroid Cancer

Study of TPX-0046, A RET/SRC Inhibitor in Adult Subjects With Advanced Solid Tumors Harboring RET Fusions or Mutations

A Study of TY-1091 in Patients With Advanced Solid Tumors

A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).