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

NCT01298323 | Completed Phase 3 Results

• 3 other identifiers: D4200C00088LPS148152010-023428-26
• Study Type: interventional
• Target: 205
• Locations: 19 countries
• Sites: 64

Brief 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

Conditions

Medullary Thyroid Cancer; Locally Advanced or Metastatic Medullary Thyroid Cancer

Keywords

Medullary Thyroid Cancer; Locally advanced; Metastatic; Vandetanib; Patient Outreach

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

Vandetanib Control

ACTIVE COMPARATOR

Control - treatment 300mg vandetanib opel label

Drug: Vandetanib

Experimental

EXPERIMENTAL

Experimental - treatment 300mg vandetanib opel label

Behavioral: Patient outreach; Drug: Vandetanib

Interventions

Patient outreach BEHAVIORAL

Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner

Experimental

Vandetanib DRUG

Treatment 300mg vandetanib opel label.

Also known as: SAR390530

Experimental; Vandetanib Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (66)

Investigational Site Number : 301

St Leonards, New South Wales, 2065, Australia

Location

Investigational Site Number 301

St Leonards, 2065, Australia

Location

Investigational Site Number 401

Vienna, 1901, Austria

Location

Investigational Site Number : 401

Vienna, 1901, Austria

Location

Investigational Site Number : 501

Anderlecht, 1070, Belgium

Location

Investigational Site Number 501

Brussels, 1000, Belgium

Location

Hospital De Clinicas De Porto Alegre Site Number : 701

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

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

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Investigational Site Number 701

Porto Alegre, 90035-003, Brazil

Location

Investigational Site Number 702

Ribeirão Preto, 14048-900, Brazil

Location

Investigational Site Number 901

Sofia, 1527, Bulgaria

Location

Investigational Site Number : 901

Sofia, 1527, Bulgaria

Location

Investigational Site Number : 1001

London, Ontario, N6A 4L6, Canada

Location

Investigational Site Number : 1003

Toronto, Ontario, M5G2M9, Canada

Location

Investigational Site Number : 1002

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Investigational Site Number 1001

London, N6A 4L6, Canada

Location

Investigational Site Number 1002

Sherbrooke, J1H 5N4, Canada

Location

Investigational Site Number 1003

Toronto, M5G2M9, Canada

Location

Investigational Site Number 1301

Beijing, 100021, China

Location

Investigational Site Number : 1301

Beijing, 100021, China

Location

Investigational Site Number 1302

Shanghai, China

Location

Investigational Site Number : 1302

Shanghai, China

Location

Investigational Site Number 1901

Prague, 15006, Czechia

Location

Investigational Site Number : 1901

Prague, 15006, Czechia

Location

Investigational Site Number 2001

Odense C, 5000, Denmark

Location

Investigational Site Number : 2001

Odense C, 5000, Denmark

Location

Investigational Site Number 2201

Helsinki, FI-00029, Finland

Location

Investigational Site Number : 2201

Helsinki, FI-00029, Finland

Location

Investigational Site Number 2602

Essen, 45122, Germany

Location

Investigational Site Number : 2602

Essen, 45122, Germany

Location

Investigational Site Number 2603

Halle, 06120, Germany

Location

Investigational Site Number : 2603

Halle, 06120, Germany

Location

Investigational Site Number 2601

Würzburg, 97080, Germany

Location

Investigational Site Number : 2601

Würzburg, 97080, Germany

Location

Investigational Site Number 3001

Athens, 11528, Greece

Location

Investigational Site Number : 3001

Athens, 11528, Greece

Location

Investigational Site Number 3501

Mumbai, 400012, India

Location

Investigational Site Number : 3501

Mumbai, 400012, India

Location

Investigational Site Number 3502

Vellore, 632004, India

Location

Investigational Site Number : 3502

Vellore, 632004, India

Location

Investigational Site Number 4001

Jerusalem, 91120, Israel

Location

Investigational Site Number : 4001

Jerusalem, 91120, Israel

Location

Investigational Site Number 4104

Naples, Italy

Location

Investigational Site Number : 4104

Naples, Italy

Location

Investigational Site Number 4101

Pisa, 56124, Italy

Location

Investigational Site Number : 4101

Pisa, 56124, Italy

Location

Investigational Site Number 4102

Roma, 00161, Italy

Location

Investigational Site Number : 4102

Roma, 00161, Italy

Location

Investigational Site Number : 5702

Poznan, Greater Poland Voivodeship, 60-355, Poland

Location

Investigational Site Number : 5703

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Investigational Site Number 5702

Poznan, 60-355, Poland

Location

Investigational Site Number 5703

Warsaw, 02-781, Poland

Location

Investigational Site Number 6201

Moscow, 115478, Russia

Location

Investigational Site Number : 6201

Moscow, 115478, Russia

Location

Investigational Site Number 6204

Moscow, 125284, Russia

Location

Investigational Site Number 6202

Obninsk, 249036, Russia

Location

Investigational Site Number : 6202

Obninsk, 249036, Russia

Location

Investigational Site Number 6203

Saint Petersburg, 197022, Russia

Location

Investigational Site Number : 6001

Seoul, 03080, South Korea

Location

Investigational Site Number 6001

Seoul, South Korea

Location

Investigational Site Number 7201

Uppsala, 75185, Sweden

Location

Investigational Site Number : 7201

Uppsala, 75185, Sweden

Location

Investigational Site Number : 2801

Sutton, Surrey, SM25PT, United Kingdom

Location

Investigational Site Number 2802

Glasgow, G120YN, United Kingdom

Location

Investigational Site Number : 2802

Glasgow, G120YN, United Kingdom

Location

Investigational Site Number 2801

Sutton, SM25PT, United Kingdom

Location

Related Links

• D4200C00088\_CSR\_Synopsis

MeSH Terms

Conditions

Carcinoma, Medullary; Neoplasm Metastasis

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610 Ext: 6#

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 17, 2011
• Study Start: February 25, 2011
• Primary Completion: April 26, 2013
• Study Completion: March 13, 2025
• Last Updated: April 17, 2026
• Results First Posted: November 24, 2014

Record last verified: 2026-04

Locations

BE (2); DK (2); IN (4); BU (2); GB (4); CZ (2); BR (4); AU (2); FI (2); IL (2); DE (6); CA (6); IT (6); SE (2); CN (4); RU (6); KR (2); GR (2); PL (4)