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Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00537095
First Posted: September 28, 2007
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
  Purpose

This is a parallel group, randomized, double blind, placebo controlled, multicentre study designed to assess whether vandetanib (ZD6474) confers an improvement in PFS as compared to placebo in subject with locally advanced or metastatic papillary or follicular thyroid carcinoma failing or unsuitable for radioiodine therapy. The trial should be of a sufficient size so that if vandetanib (ZD6474) is truly active there is a high probability that it will demonstrate an effect sufficiently promising to warrant a follow-up assessment.

  • Subjects will be seen weekly for the first 2 weeks, then again at Week 4, Week 8, and Week 12 after randomization, and every 12 weeks thereafter. Upon disease progression, all subjects (both active and placebo) will be unblinded and given the option to discontinue blinded study treatment and enter follow up and survival, or begin open label vandetanib (ZD6474) 300 mg treatment. All subjects will be followed to collect survival data until ≥50% of subjects have died. Subjects who are taking vandetanib (ZD6474) at the time of study closure and wish to remain on therapy will be allowed to continue for as long as the Investigator feels that they are obtaining clinical benefit, or until they are given another anti-cancer therapy. The safety data from all subjects will be assessed on an ongoing basis, including discontinuation and follow up.
  • Radiologic evaluation using RECIST criteria will be performed every 12 weeks (± 2 weeks). All medical images will be centralized assessed at the site and centrally reviewed. Subjects will be evaluated until progression, and will then be followed up for survival, regardless of whether they continue randomized treatment, unless they withdraw consent. Post progression open-label vandetanib (ZD6474) will be offered at the investigators discretion.
  • All subjects must submit a suitable archived tumor sample prior to randomization. In the event that a suitable archived sample is not available within 2 weeks prior to randomization, a fresh tumor sample must be obtained in its place prior to randomization. If a subject undergoes the fresh tumor biopsy procedure, this specimen will satisfy the first optional tumor biopsy submission should they consent to the exploratory part of the study.

Condition Intervention Phase
Thyroid Neoplasms Drug: Vandetanib Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • Time to Tumor Progression [ 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 ]
    modified RECIST V1.0 was used


Secondary Outcome Measures:
  • Disease Control Rate at 6 Months [ Time Frame: 6 months after randomisation ]
    number of participants that achieved disease control 6 months after randomisation. Best objective response of complete response + partial response + stable disease > 24 weeks according to RECIST criteria

  • Objective Response Rate [ Time Frame: 46.7 months ]
    Best objective response of the participants from an average of 46.7 months, defined as complete or partial response according to RECIST criteria

  • Time to Death [ Time Frame: time from randomisation to date of death ]
    Interim analysis time to date of randomisation to date of death (data not mature at the time of this analysis, so number of deaths displayed instead.


Enrollment: 165
Actual Study Start Date: September 29, 2007
Estimated Study Completion Date: December 31, 2019
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vandetanib (ZD6474)
vandetanib (ZD6474) 300 mg per os once daily
Drug: Vandetanib
300 mg oral once daily oral dose
Other Name: SAR390530
Placebo Comparator: Placebo
Placebo
Other: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537095


Locations
Belgium
Research Site
Brussels, Belgium
Denmark
Research Site
Odense, Denmark
France
Research Site
Angers Cedex 9, France
Research Site
Angers Cedex, France
Research Site
Bordeaux Cedex, France
Research Site
Caen Cedex 5, France
Research Site
Caen Cedex, France
Research Site
Lyon Cedex, France
Research Site
Lyon, France
Research Site
Marseille Cedex 9, France
Research Site
Marseille Cedex, France
Research Site
Paris Cedex 10, France
Research Site
Paris Cedex 13, France
Research Site
Paris, France
Research Site
Villejuif Cedex, France
Research Site
Villejuif, France
Norway
Research Site
Oslo, Norway
Spain
Research Site
L'Hospitalet de Llobregat, Spain
Research Site
Madrid, Spain
Sweden
Research Site
Lund, Sweden
Research Site
Stockholm, Sweden
Switzerland
Research Site
Bern, Switzerland
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Chair: Clinical Sciences & Operations Sanofi
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00537095     History of Changes
Other Study ID Numbers: D4200C00079
2007-001890-27 ( EudraCT Number )
LPS14940 ( Other Identifier: Sanofi )
First Submitted: September 27, 2007
First Posted: September 28, 2007
Results First Submitted: April 27, 2011
Results First Posted: July 8, 2011
Last Update Posted: December 7, 2017
Last Verified: November 2017

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
follicular
papillary

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms