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NCT01298323CompletedPhase 3

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

Source: ClinicalTrials.gov · Last updated 17 Apr 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
205 (actual)
First submitted
16 Feb 2011
Start date
25 Feb 2011
Primary completion date
26 Apr 2013
Lead sponsor
Sanofi
NCT number
NCT01298323
EudraCT number
2010-023428-26

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 205
  • From 25 Feb 2011 to the primary completion date, 26 Apr 2013
  • 37 sites in 20 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Lab values

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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ViennaAustriaUnknown status
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St LeonardsAustraliaUnknown status
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AnderlechtBelgiumUnknown status
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BrusselsBelgiumUnknown status
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SofiaBulgariaUnknown status
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Porto AlegreBrazilUnknown status
Hospital De Clinicas De Porto Alegre Site Number : 701
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Porto AlegreBrazilUnknown status
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Ribeirão PretoBrazilUnknown status
Faculdade de Medicina de Ribeirao Preto - USP Site Number : 702
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Ribeirão PretoBrazilUnknown status
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LondonCanadaUnknown status
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SherbrookeCanadaUnknown status
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TorontoCanadaUnknown status
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BeijingChinaUnknown status
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ShanghaiChinaUnknown status
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PragueCzechiaUnknown status
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EssenGermanyUnknown status
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HalleGermanyUnknown status
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WürzburgGermanyUnknown status
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Odense CDenmarkUnknown status
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HelsinkiFinlandUnknown status
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GlasgowUnited KingdomUnknown status
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SuttonUnited KingdomUnknown status
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AthensGreeceUnknown status
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JerusalemIsraelUnknown status
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MumbaiIndiaUnknown status
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VelloreIndiaUnknown status
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NaplesItalyUnknown status
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PisaItalyUnknown status
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RomaItalyUnknown status
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SeoulSouth KoreaUnknown status
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PoznanPolandUnknown status
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WarsawPolandUnknown status
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MoscowRussiaUnknown status
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MoscowRussiaUnknown status
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ObninskRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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UppsalaSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.