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 (88)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Locally Advanced or Metastatic Medullary Thyroid Cancer; Medullary Thyroid Cancer	Behavioral: Patient outreach; Drug: Vandetanib	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	205 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	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
Actual Study Start Date :	February 25, 2011
Actual Primary Completion Date :	April 2013
Estimated Study Completion Date :	December 31, 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Vandetanib Control; Control - treatment 300mg vandetanib opel label	Drug: Vandetanib; Treatment 300mg vandetanib opel label.; Other Name: SAR390530
Experimental: Experimental; Experimental - treatment 300mg vandetanib opel label	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.; Other Name: SAR390530

Outcome Measures

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Primary Outcome Measures :

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. [ Time Frame: 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 34 Study Locations

Sponsors and Collaborators

Genzyme, a Sanofi Company

Investigators

Study Director:	Clinical Sciences & Operations	Sanofi

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

D4200C00088_CSR_Synopsis 

Responsible Party:	Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:	NCT01298323 History of Changes
Other Study ID Numbers:	D4200C00088; 2010-023428-26 ( EudraCT Number ); LPS14815 ( Other Identifier: Sanofi )
First Posted:	February 17, 2011
Results First Posted:	November 24, 2014
Last Update Posted:	December 7, 2017
Last Verified:	November 2017

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):

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

Additional relevant MeSH terms:

Thyroid Diseases; Thyroid Neoplasms; Carcinoma, Neuroendocrine; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms	Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue