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A Randomized, Double Blind, Placebo-controlled Phase II, Multi-Centre Study to Assess the Efficacy and Safety of Vandetanib (ZD6474) in Patients With Locally Advanced or Metastatic Papillary or Follicular Thyroid Carcinoma Failing or Unsuitable for Radioiodine Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Thyroid Neoplasms

Thank you

Trial Information

A Randomized, Double Blind, Placebo-controlled Phase II, Multi-Centre Study to Assess the Efficacy and Safety of Vandetanib (ZD6474) in Patients With Locally Advanced or Metastatic Papillary or Follicular Thyroid Carcinoma Failing or Unsuitable for Radioiodine Therapy


Inclusion Criteria:



- Previously confirmed histological diagnosis of locally advanced or metastatic
papillary or follicular thyroid carcinoma, without anaplastic component. Tumor sample
available for centralized exploratory analysis.

- Presence of one or more measurable lesions at least 1 cm in the longest diameter by
spiral CT scan or 2 cm with conventional techniques.

- Progressive disease following RAI131 or patient unsuitable for RAI131 after surgery.

- Serum TSH<0.5mU/L.

Exclusion Criteria:

- Major surgery within 4 weeks before randomization.

- Prior chemotherapy within the last 4 weeks prior to randomization.

- RAI131 therapy within 3 months in patients with radioiodine uptake.

- Radiation therapy within the last 4 weeks prior to randomization (with the exception
of palliative radiotherapy).

- Serum bilirubin >1.5 x the upper limit of reference range (ULRR).

- Creatinine clearance < 30 ml/min (calculated by Cockcroft-Gault formula).

- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline
phosphatase (ALP) greater than 2.5 × ULRR, or greater than 5.0 × ULRR if judged by
the investigator to be related to liver metastases.

- Clinically significant cardiovascular event (eg myocardial infarction), superior vena
cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart
failure >II within 3 months before entry, or presence of cardiac disease that in the
opinion of the Investigator increases the risk of ventricular arrhythmia.

- History of arrhythmia (multifocal premature ventricular contractions [PVCs],
bigeminy, trigeminy, ventricular tachycardia or uncontrolled atrial fibrillation),
which is symptomatic or requires treatment (CTCAE grade 3), , or asymptomatic
sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by
medication are permitted.

- Congenital long QT syndrome or 1st degree relative with unexplained sudden death
under 40 years of age.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to Tumor Progression

Outcome Description:

modified RECIST V1.0 was used

Outcome Time Frame:

Time from date of randomisation to date of the first documented tumor progression or date of death from any cause (within the 3 months) of tumor assessment

Safety Issue:

No

Principal Investigator

Annie Tisseron

Investigator Role:

Study Chair

Investigator Affiliation:

AstraZeneca

Authority:

Denmark: Danish Medicines Agency

Study ID:

D4200C00079

NCT ID:

NCT00537095

Start Date:

September 2007

Completion Date:

June 2012

Related Keywords:

  • Thyroid Neoplasms
  • follicular
  • papillary
  • Neoplasms
  • Thyroid Neoplasms
  • Thyroid Diseases
  • Adenocarcinoma, Follicular

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