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 - Full Text View

Purpose

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	Intervention	Phase
Locally Advanced or Metastatic Medullary Thyroid Cancer Medullary Thyroid Cancer	Behavioral: Patient outreach Drug: Vandetanib	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Vandetanib

Genetic and Rare Diseases Information Center resources: Thyroid Cancer, Medullary Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:

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.


Enrollment:	205
Study Start Date:	February 2011
Estimated Study Completion Date:	December 2017
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298323

Show 34 Study Locations

Sponsors and Collaborators

Genzyme, a Sanofi Company

Investigators


Study Director:	Clinical Sciences & Operations	Sanofi

More Information

Additional Information:

D4200C00088_CSR_Synopsis This link exits the ClinicalTrials.gov site


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 )
Study First Received:	February 16, 2011
Results First Received:	April 25, 2014
Last Updated:	January 5, 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

ClinicalTrials.gov processed this record on June 26, 2017

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)