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

Medullary Thyroid Cancer Clinical Trial

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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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01298323
• Other study ID #: D4200C00088
• Secondary ID: 2010-023428-26LP
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 25, 2011
• Est. completion date: June 28, 2024

Study information

• Verified date: September 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 205
• Est. completion date: June 28, 2024
• Est. primary completion date: April 26, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Neuroendocrine
• Locally Advanced or Metastatic Medullary Thyroid Cancer
• Medullary Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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

Drug:
• Vandetanib
Treatment 300mg vandetanib opel label.

Locations

Country	Name	City	State
Australia	Investigational Site Number 301	St Leonards
Austria	Investigational Site Number 401	Wien
Belgium	Investigational Site Number 501	Bruxelles
Brazil	Investigational Site Number 701	Porto Alegre
Brazil	Investigational Site Number 702	Ribeirão Preto
Bulgaria	Investigational Site Number 901	Sofia
Canada	Investigational Site Number 1001	London
Canada	Investigational Site Number 1002	Sherbrooke
Canada	Investigational Site Number 1003	Toronto
China	Investigational Site Number 1301	Beijing
China	Investigational Site Number 1302	Shanghai
Czechia	Investigational Site Number 1901	Praha
Denmark	Investigational Site Number 2001	Odense C
Finland	Investigational Site Number 2201	Helsinki
Germany	Investigational Site Number 2602	Essen
Germany	Investigational Site Number 2603	Halle
Germany	Investigational Site Number 2601	Würzburg
Greece	Investigational Site Number 3001	Athens
India	Investigational Site Number 3501	Mumbai
India	Investigational Site Number 3502	Vellore
Israel	Investigational Site Number 4001	Jerusalem
Italy	Investigational Site Number 4104	Napoli
Italy	Investigational Site Number 4101	Pisa
Italy	Investigational Site Number 4102	Roma
Korea, Republic of	Investigational Site Number 6001	Seoul
Poland	Investigational Site Number 5702	Poznan
Poland	Investigational Site Number 5703	Warsaw
Russian Federation	Investigational Site Number 6201	Moscow
Russian Federation	Investigational Site Number 6204	Moscow
Russian Federation	Investigational Site Number 6202	Obninsk
Russian Federation	Investigational Site Number 6203	St Petersburg
Sweden	Investigational Site Number 7201	Uppsala
United Kingdom	Investigational Site Number 2802	Glasgow
United Kingdom	Investigational Site Number 2801	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czechia,  Denmark,  Finland,  Germany,  Greece,  India,  Israel,  Italy,  Korea, Republic of,  Poland,  Russian Federation,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   D4200C00088_CSR_Synopsis