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 (88)

April 15, 2026 updated by: Sanofi

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
205

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • St Leonards, Australia, 2065
        • Investigational Site Number 301
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Investigational Site Number : 301
  • Austria
      • Vienna, Austria, 1901
        • Investigational Site Number 401
      • Vienna, Austria, 1901
        • Investigational Site Number : 401
  • Belgium
      • Anderlecht, Belgium, 1070
        • Investigational Site Number : 501
      • Brussels, Belgium, 1000
        • Investigational Site Number 501
  • Brazil
      • Porto Alegre, Brazil, 90035-003
        • Investigational Site Number 701
      • Ribeirão Preto, Brazil, 14048-900
        • Investigational Site Number 702
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
        • Hospital De Clinicas De Porto Alegre Site Number : 701
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14048-900
        • Faculdade de Medicina de Ribeirao Preto - USP Site Number : 702
  • Bulgaria
      • Sofia, Bulgaria, 1527
        • Investigational Site Number 901
      • Sofia, Bulgaria, 1527
        • Investigational Site Number : 901
  • Canada
      • London, Canada, N6A 4L6
        • Investigational Site Number 1001
      • Sherbrooke, Canada, J1H 5N4
        • Investigational Site Number 1002
      • Toronto, Canada, M5G2M9
        • Investigational Site Number 1003
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Investigational Site Number : 1001
      • Toronto, Ontario, Canada, M5G2M9
        • Investigational Site Number : 1003
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Investigational Site Number : 1002
  • China
      • Beijing, China, 100021
        • Investigational Site Number 1301
      • Beijing, China, 100021
        • Investigational Site Number : 1301
      • Shanghai, China
        • Investigational Site Number 1302
      • Shanghai, China
        • Investigational Site Number : 1302
  • Czechia
      • Prague, Czechia, 15006
        • Investigational Site Number : 1901
      • Prague, Czechia, 15006
        • Investigational Site Number 1901
  • Denmark
      • Odense C, Denmark, 5000
        • Investigational Site Number 2001
      • Odense C, Denmark, 5000
        • Investigational Site Number : 2001
  • Finland
      • Helsinki, Finland, FI-00029
        • Investigational Site Number 2201
      • Helsinki, Finland, FI-00029
        • Investigational Site Number : 2201
  • Germany
      • Essen, Germany, 45122
        • Investigational Site Number 2602
      • Essen, Germany, 45122
        • Investigational Site Number : 2602
      • Halle, Germany, 06120
        • Investigational Site Number 2603
      • Halle, Germany, 06120
        • Investigational Site Number : 2603
      • Würzburg, Germany, 97080
        • Investigational Site Number 2601
      • Würzburg, Germany, 97080
        • Investigational Site Number : 2601
  • Greece
      • Athens, Greece, 11528
        • Investigational Site Number 3001
      • Athens, Greece, 11528
        • Investigational Site Number : 3001
  • India
      • Mumbai, India, 400012
        • Investigational Site Number 3501
      • Mumbai, India, 400012
        • Investigational Site Number : 3501
      • Vellore, India, 632004
        • Investigational Site Number 3502
      • Vellore, India, 632004
        • Investigational Site Number : 3502
  • Israel
      • Jerusalem, Israel, 91120
        • Investigational Site Number 4001
      • Jerusalem, Israel, 91120
        • Investigational Site Number : 4001
  • Italy
      • Naples, Italy
        • Investigational Site Number 4104
      • Naples, Italy
        • Investigational Site Number : 4104
      • Pisa, Italy, 56124
        • Investigational Site Number 4101
      • Pisa, Italy, 56124
        • Investigational Site Number : 4101
      • Roma, Italy, 00161
        • Investigational Site Number 4102
      • Roma, Italy, 00161
        • Investigational Site Number : 4102
  • Poland
      • Poznan, Poland, 60-355
        • Investigational Site Number 5702
      • Warsaw, Poland, 02-781
        • Investigational Site Number 5703
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-355
        • Investigational Site Number : 5702
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Investigational Site Number : 5703
  • Russia
      • Moscow, Russia, 115478
        • Investigational Site Number 6201
      • Moscow, Russia, 115478
        • Investigational Site Number : 6201
      • Moscow, Russia, 125284
        • Investigational Site Number 6204
      • Obninsk, Russia, 249036
        • Investigational Site Number 6202
      • Obninsk, Russia, 249036
        • Investigational Site Number : 6202
      • Saint Petersburg, Russia, 197022
        • Investigational Site Number 6203
  • South Korea
      • Seoul, South Korea, 03080
        • Investigational Site Number : 6001
      • Seoul, South Korea
        • Investigational Site Number 6001
  • Sweden
      • Uppsala, Sweden, 75185
        • Investigational Site Number 7201
      • Uppsala, Sweden, 75185
        • Investigational Site Number : 7201
  • United Kingdom
      • Glasgow, United Kingdom, G120YN
        • Investigational Site Number 2802
      • Glasgow, United Kingdom, G120YN
        • Investigational Site Number : 2802
      • Sutton, United Kingdom, SM25PT
        • Investigational Site Number 2801
    • Surrey
      • Sutton, Surrey, United Kingdom, SM25PT
        • Investigational Site Number : 2801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Vandetanib Control
Control - treatment 300mg vandetanib opel label
Drug: Vandetanib
Treatment 300mg vandetanib opel label.
Other Names:
  • SAR390530
Experimental: Experimental
Experimental - treatment 300mg vandetanib opel label
Drug: Vandetanib
Treatment 300mg vandetanib opel label.
Other Names:
  • SAR390530
Behavioral: Patient outreach
Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.
Time Frame: 12 months
The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D4200C00088
  • 2010-023428-26 (EudraCT Number)
  • LPS14815 (Other Identifier: Sanofi Identifier)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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