Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma.
A Phase I/II, Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
300 mg oral dose once daily (100 mg x 3 tablets)
Research Site
Fukuoka, Japan
Research Site
Kobe, Japan
Research Site
Kōtoku, Japan
Research Site
Shinjuku-ku, Japan
Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib
ORR is defined as the percentage of patients who have a confirmed CR (Disappearance of all target lesions) or PR (\>=30% decrease in the sum of diameters of target lesions) prior to any evidence of progression as defined by RECIST V1.1. This percentage is calculated with only patients who had at least measurable lesion in the efficacy analysis set.
Time frame: Sept 2012 to May 2014
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.