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 Endpoint Classification: Safety Study 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:

MedlinePlus related topics: Cancer Thyroid Cancer Thyroid Diseases

Drug Information available for: Vandetanib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program. [ Time Frame: AEs will be collected over 52 weeks on treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Frequency and severity of adverse events. [ Time Frame: Over the 52 weeks on study treatment and 60 day follow up ] [ Designated as safety issue: Yes ]
Vital signs including pulse rate and blood pressure. [ Time Frame: Over the 52 weeks on study treatment ] [ Designated as safety issue: Yes ]
Clinically significant laboratory abnormalities. [ Time Frame: Over the 52 weeks on study treatment ] [ Designated as safety issue: Yes ]
ECG abnormalities ECG abnormalities. [ Time Frame: Over the 52 weeks on study treatment ] [ Designated as safety issue: Yes ]

Enrollment:	217
Study Start Date:	February 2011
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 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.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

Show 33 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Lars Bastholt, MD DPM

Odense University Hospital

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01298323 History of Changes
Other Study ID Numbers:	D4200C00088, 2010-023428-26
Study First Received:	February 16, 2011
Last Updated:	April 5, 2013
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Agency for Health and Food Safety Belgium: Federal Agency for Medicinal Products and Health Products Brazil: National Health Surveillance Agency Bulgaria: Ministry of Health Canada: Canadian Institutes of Health Research China: Food and Drug Administration Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines India: Ministry of Health Israel: Israeli Health Ministry Pharmaceutical Administration Italy: The Italian Medicines Agency Korea: Food and Drug Administration Norway: Norwegian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: State Institute for Drug Control Russia: FSI Scientific Center of Expertise of Medical Application Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Medullary Thyroid Cancer
Locally advanced
Metastatic
Vandetanib
Patient Outreach

Additional relevant MeSH terms:

Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site

Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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)