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)

September 22, 2023 updated by: Genzyme, a Sanofi Company

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • 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
  • Austria
      • Wien, Austria, 1901
        • Investigational Site Number 401
  • Belgium
      • Bruxelles, 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
  • Bulgaria
      • 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
  • China
      • Beijing, China, 100021
        • Investigational Site Number 1301
      • Shanghai, China
        • Investigational Site Number 1302
  • Czechia
      • Praha, Czechia, 15006
        • Investigational Site Number 1901
  • Denmark
      • Odense C, Denmark, 5000
        • Investigational Site Number 2001
  • Finland
      • Helsinki, Finland, FI-00029
        • Investigational Site Number 2201
  • Germany
      • Essen, Germany, 45122
        • Investigational Site Number 2602
      • Halle, Germany, 06120
        • Investigational Site Number 2603
      • Würzburg, Germany, 97080
        • Investigational Site Number 2601
  • Greece
      • Athens, Greece, 11528
        • Investigational Site Number 3001
  • India
      • Mumbai, India, 400012
        • Investigational Site Number 3501
      • Vellore, India, 632004
        • Investigational Site Number 3502
  • Israel
      • Jerusalem, Israel, 91120
        • Investigational Site Number 4001
  • Italy
      • Napoli, Italy
        • Investigational Site Number 4104
      • Pisa, Italy, 56124
        • Investigational Site Number 4101
      • Roma, Italy, 00161
        • Investigational Site Number 4102
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Investigational Site Number 6001
  • Poland
      • Poznan, Poland, 60-355
        • Investigational Site Number 5702
      • Warsaw, Poland, 02-781
        • Investigational Site Number 5703
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Investigational Site Number 6201
      • Moscow, Russian Federation, 125284
        • Investigational Site Number 6204
      • Obninsk, Russian Federation, 249036
        • Investigational Site Number 6202
      • St Petersburg, Russian Federation, 197022
        • Investigational Site Number 6203
  • Sweden
      • Uppsala, Sweden, 75185
        • Investigational Site Number 7201
  • United Kingdom
      • Glasgow, United Kingdom, G120YN
        • Investigational Site Number 2802
      • Sutton, 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

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
Intervention / Treatment
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

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

Genzyme, a Sanofi Company

Investigators

  • 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)

February 25, 2011

Primary Completion (Actual)

April 26, 2013

Study Completion (Estimated)

June 28, 2024

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimated)

February 17, 2011

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4200C00088
  • 2010-023428-26 (EudraCT Number)
  • LPS14815 (Other Identifier: Sanofi)

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.

Clinical Trials on Medullary Thyroid Cancer

Clinical Trials on Vandetanib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe