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 identifier:D4200C00088

ClinicalTrials.gov identifier:NCT01298323

EudraCT identifier:2010-023428-26

CTIS identifier:N/A

Recruitment Complete

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

Medical condition

Locally Advanced or Metastatic Medullary Thyroid Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Vandetanib

Sex

All

Actual Enrollment

217

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 01 Feb 2011
Primary Completion Date: 01 Apr 2013
Estimated Study Completion Date: 01 Jun 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria