Clinical trial NCT01298323: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Locally Advanced or Metastatic Medullary Thyroid Cancer
Medullary Thyroid Cancer
Keywords: Medullary Thyroid Cancer
Locally advanced
Metastatic
Vandetanib
Patient Outreach
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-02-17
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: Investigational Site Number : 301
state: New South Wales
city: St Leonards
country: Australia
facility: Investigational Site Number 301
city: Wien
country: Austria
facility: Investigational Site Number 401
city: Wien
country: Austria
facility: Investigational Site Number : 401
city: Anderlecht
country: Belgium
facility: Investigational Site Number : 501
city: Bruxelles
country: Belgium
facility: Investigational Site Number 501
city: Porto Alegre
country: Brazil
facility: Hospital De Clinicas De Porto Alegre Site Number : 701
state: Rio Grande Do Sul
city: Ribeirao Preto
country: Brazil
facility: Faculdade de Medicina de Ribeirao Preto - USP Site Number : 702
state: São Paulo
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 701
city: Ribeirão Preto
country: Brazil
facility: Investigational Site Number 702
city: Sofia
country: Bulgaria
facility: Investigational Site Number 901
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 901
city: London
country: Canada
facility: Investigational Site Number : 1001
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1003
state: Ontario
city: Sherbrooke
country: Canada
facility: Investigational Site Number : 1002
state: Quebec
city: London
country: Canada
facility: Investigational Site Number 1001
city: Sherbrooke
country: Canada
facility: Investigational Site Number 1002
city: Toronto
country: Canada
facility: Investigational Site Number 1003
city: Beijing
country: China
facility: Investigational Site Number 1301
city: Beijing
country: China
facility: Investigational Site Number : 1301
city: Shanghai
country: China
facility: Investigational Site Number 1302
city: Shanghai
country: China
facility: Investigational Site Number : 1302
city: Praha
country: Czechia
facility: Investigational Site Number 1901
city: Praha
country: Czechia
facility: Investigational Site Number : 1901
city: Odense C
country: Denmark
facility: Investigational Site Number 2001
city: Odense C
country: Denmark
facility: Investigational Site Number : 2001
city: Helsinki
country: Finland
facility: Investigational Site Number 2201
city: Helsinki
country: Finland
facility: Investigational Site Number : 2201
city: Essen
country: Germany
facility: Investigational Site Number 2602
city: Essen
country: Germany
facility: Investigational Site Number : 2602
city: Halle
country: Germany
facility: Investigational Site Number 2603
city: Halle
country: Germany
facility: Investigational Site Number : 2603
city: Würzburg
country: Germany
facility: Investigational Site Number 2601
city: Würzburg
country: Germany
facility: Investigational Site Number : 2601
city: Athens
country: Greece
facility: Investigational Site Number 3001
city: Athens
country: Greece
facility: Investigational Site Number : 3001
city: Mumbai
country: India
facility: Investigational Site Number 3501
city: Mumbai
country: India
facility: Investigational Site Number : 3501
city: Vellore
country: India
facility: Investigational Site Number 3502
city: Vellore
country: India
facility: Investigational Site Number : 3502
city: Jerusalem
country: Israel
facility: Investigational Site Number 4001
city: Jerusalem
country: Israel
facility: Investigational Site Number : 4001
city: Napoli
country: Italy
facility: Investigational Site Number 4104
city: Napoli
country: Italy
facility: Investigational Site Number : 4104
city: Pisa
country: Italy
facility: Investigational Site Number 4101
city: Pisa
country: Italy
facility: Investigational Site Number : 4101
city: Roma
country: Italy
facility: Investigational Site Number 4102
city: Roma
country: Italy
facility: Investigational Site Number : 4102
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 6001
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 6001
city: Warsaw
country: Poland
facility: Investigational Site Number : 5703
state: Mazowieckie
city: Poznan
country: Poland
facility: Investigational Site Number : 5702
state: Wielkopolskie
city: Poznan
country: Poland
facility: Investigational Site Number 5702
city: Warsaw
country: Poland
facility: Investigational Site Number 5703
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6201
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6201
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6204
city: Obninsk
country: Russian Federation
facility: Investigational Site Number 6202
city: Obninsk
country: Russian Federation
facility: Investigational Site Number : 6202
city: St Petersburg
country: Russian Federation
facility: Investigational Site Number 6203
city: Uppsala
country: Sweden
facility: Investigational Site Number 7201
city: Uppsala
country: Sweden
facility: Investigational Site Number : 7201
city: Sutton
country: United Kingdom
facility: Investigational Site Number : 2801
state: Surrey
city: Glasgow
country: United Kingdom
facility: Investigational Site Number 2802
city: Glasgow
country: United Kingdom
facility: Investigational Site Number : 2802
city: Sutton
country: United Kingdom
facility: Investigational Site Number 2801
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: