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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01298323




Registration number
NCT01298323
Ethics application status
Date submitted
16/02/2011
Date registered
17/02/2011
Date last updated
9/12/2019

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2010-023428-26
Secondary ID [2] 0 0
D4200C00088
Universal Trial Number (UTN)
Trial acronym
88
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic Medullary Thyroid Cancer 0 0
Medullary Thyroid Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Thyroid
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Patient outreach
Treatment: Drugs - Vandetanib

Active Comparator: Vandetanib Control - Control - treatment 300mg vandetanib opel label

Experimental: Experimental - Experimental - treatment 300mg vandetanib opel label


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

Treatment: Drugs: Vandetanib
Treatment 300mg vandetanib opel label.

Intervention code [1] 0 0
Behaviour
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 301 - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Brazil
State/province [3] 0 0
Porto Alegre
Country [4] 0 0
Brazil
State/province [4] 0 0
Ribeirão Preto
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Sofia
Country [6] 0 0
Canada
State/province [6] 0 0
London
Country [7] 0 0
Canada
State/province [7] 0 0
Sherbrooke
Country [8] 0 0
Canada
State/province [8] 0 0
Toronto
Country [9] 0 0
China
State/province [9] 0 0
Beijing
Country [10] 0 0
China
State/province [10] 0 0
Shanghai
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha
Country [12] 0 0
Denmark
State/province [12] 0 0
Odense C
Country [13] 0 0
Finland
State/province [13] 0 0
Helsinki
Country [14] 0 0
Germany
State/province [14] 0 0
Essen
Country [15] 0 0
Germany
State/province [15] 0 0
Halle
Country [16] 0 0
Germany
State/province [16] 0 0
Würzburg
Country [17] 0 0
Greece
State/province [17] 0 0
Athens
Country [18] 0 0
India
State/province [18] 0 0
Mumbai
Country [19] 0 0
India
State/province [19] 0 0
Vellore
Country [20] 0 0
Israel
State/province [20] 0 0
Jerusalem
Country [21] 0 0
Italy
State/province [21] 0 0
Napoli
Country [22] 0 0
Italy
State/province [22] 0 0
Pisa
Country [23] 0 0
Italy
State/province [23] 0 0
Roma
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul
Country [25] 0 0
Poland
State/province [25] 0 0
Poznan
Country [26] 0 0
Poland
State/province [26] 0 0
Warsaw
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Moscow
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Obninsk
Country [29] 0 0
Russian Federation
State/province [29] 0 0
St Petersburg
Country [30] 0 0
Sweden
State/province [30] 0 0
Uppsala
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Glasgow
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genzyme, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT01298323
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications