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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01298323
First received: February 16, 2011
Last updated: January 8, 2014
Last verified: January 2014
  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:


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: 205
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
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.
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
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 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: January 8, 2014
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 Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014