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
- Conditions
- Locally Advanced or Metastatic Medullary Thyroid CancerMedullary Thyroid Cancer
- Interventions
- Behavioral: Patient outreachDrug: Vandetanib
- Registration Number
- NCT01298323
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 205
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Patient outreach Experimental - treatment 300mg vandetanib opel label Vandetanib Control Vandetanib Control - treatment 300mg vandetanib opel label Experimental Vandetanib Experimental - treatment 300mg vandetanib opel label
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (66)
Investigational Site Number : 301
🇦🇺St Leonards, New South Wales, Australia
Investigational Site Number : 401
🇦🇹Wien, Austria
Investigational Site Number : 501
🇧🇪Anderlecht, 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
🇧🇷Ribeirao Preto, São Paulo, Brazil
Investigational Site Number : 901
🇧🇬Sofia, Bulgaria
Investigational Site Number : 1001
🇨🇦London, Ontario, Canada
Investigational Site Number : 1003
🇨🇦Toronto, Ontario, Canada
Investigational Site Number : 1901
🇨🇿Praha, Czechia
Investigational Site Number : 2001
🇩🇰Odense C, Denmark
Investigational Site Number : 1002
🇨🇦Sherbrooke, Quebec, Canada
Investigational Site Number : 1301
🇨🇳Beijing, China
Investigational Site Number : 1302
🇨🇳Shanghai, China
Investigational Site Number : 2201
🇫🇮Helsinki, Finland
Investigational Site Number : 2602
🇩🇪Essen, Germany
Investigational Site Number : 2603
🇩🇪Halle, Germany
Investigational Site Number : 2601
🇩🇪Würzburg, Germany
Investigational Site Number : 3001
🇬🇷Athens, Greece
Investigational Site Number : 3501
🇮🇳Mumbai, India
Investigational Site Number : 3502
🇮🇳Vellore, India
Investigational Site Number : 4001
🇮🇱Jerusalem, Israel
Investigational Site Number : 4104
🇮🇹Napoli, Italy
Investigational Site Number : 4102
🇮🇹Roma, Italy
Investigational Site Number : 4101
🇮🇹Pisa, Italy
Investigational Site Number : 6001
🇰🇷Seoul, Korea, Republic of
Investigational Site Number : 5703
🇵🇱Warsaw, Mazowieckie, Poland
Investigational Site Number : 6201
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6202
🇷🇺Obninsk, Russian Federation
Investigational Site Number : 5702
🇵🇱Poznan, Wielkopolskie, Poland
Investigational Site Number : 7201
🇸🇪Uppsala, Sweden
Investigational Site Number : 2801
🇬🇧Sutton, Surrey, United Kingdom
Investigational Site Number : 2802
🇬🇧Glasgow, United Kingdom
Investigational Site Number 301
🇦🇺St Leonards, Australia
Investigational Site Number 401
🇦🇹Wien, Austria
Investigational Site Number 501
🇧🇪Bruxelles, Belgium
Investigational Site Number 702
🇧🇷Ribeirão Preto, Brazil
Investigational Site Number 701
🇧🇷Porto Alegre, Brazil
Investigational Site Number 901
🇧🇬Sofia, Bulgaria
Investigational Site Number 1001
🇨🇦London, Canada
Investigational Site Number 1002
🇨🇦Sherbrooke, Canada
Investigational Site Number 1302
🇨🇳Shanghai, China
Investigational Site Number 1003
🇨🇦Toronto, Canada
Investigational Site Number 1301
🇨🇳Beijing, China
Investigational Site Number 1901
🇨🇿Praha, Czechia
Investigational Site Number 2001
🇩🇰Odense C, Denmark
Investigational Site Number 2602
🇩🇪Essen, Germany
Investigational Site Number 2603
🇩🇪Halle, Germany
Investigational Site Number 2601
🇩🇪Würzburg, Germany
Investigational Site Number 2201
🇫🇮Helsinki, Finland
Investigational Site Number 3001
🇬🇷Athens, Greece
Investigational Site Number 3501
🇮🇳Mumbai, India
Investigational Site Number 4001
🇮🇱Jerusalem, Israel
Investigational Site Number 3502
🇮🇳Vellore, India
Investigational Site Number 4104
🇮🇹Napoli, Italy
Investigational Site Number 4101
🇮🇹Pisa, Italy
Investigational Site Number 4102
🇮🇹Roma, Italy
Investigational Site Number 6001
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 6204
🇷🇺Moscow, Russian Federation
Investigational Site Number 5702
🇵🇱Poznan, Poland
Investigational Site Number 6202
🇷🇺Obninsk, Russian Federation
Investigational Site Number 5703
🇵🇱Warsaw, Poland
Investigational Site Number 6201
🇷🇺Moscow, Russian Federation
Investigational Site Number 6203
🇷🇺St Petersburg, Russian Federation
Investigational Site Number 7201
🇸🇪Uppsala, Sweden
Investigational Site Number 2802
🇬🇧Glasgow, United Kingdom
Investigational Site Number 2801
🇬🇧Sutton, United Kingdom