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

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.
 
ClinicalTrials.gov Identifier: NCT00537095
Recruitment Status : Completed
First Posted : September 28, 2007
Results First Posted : July 8, 2011
Last Update Posted : April 19, 2024
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Description
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Brief Summary:

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

  • Participants were 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 participants (both active and placebo) were 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 participants were followed to collect survival data until greater than or equal to (>=) 50% of participants had died. Participants who were taking vandetanib (ZD6474) at the time of study closure and wished to remain on therapy were allowed to continue for as long as the Investigator felt that they were obtaining clinical benefit, or until they were given another anti-cancer therapy. The safety data from all participants was assessed on an ongoing basis, including discontinuation and follow up.
  • Radiologic evaluation using RECIST criteria was performed every 12 weeks (+/- 2 weeks). All medical images were centralized assessed at the site and centrally reviewed. Participants were evaluated until progression, and then followed up for survival, regardless of whether they continued randomized treatment, unless they withdrew consent. Post progression open-label vandetanib (ZD6474) were offered at the investigators discretion.
  • All participants submitted a suitable archived tumor sample prior to randomization. In the event that a suitable archived sample was not available within 2 weeks prior to randomization, a fresh tumor sample was obtained in its place prior to randomization. If a participant underwent the fresh tumor biopsy procedure, this specimen would satisfy the first optional tumor biopsy submission should they consented to the exploratory part of the study.

Condition or disease Intervention/treatment Phase
Thyroid Neoplasms Drug: Vandetanib Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
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
Actual Study Start Date : September 28, 2007
Actual Primary Completion Date : December 2, 2009
Actual Study Completion Date : November 24, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Vandetanib

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Time to Tumor Progression [ Time Frame: Time from date of randomization 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 :
  1. Disease Control Rate at 6 Months [ Time Frame: 6 months after randomization ]
    number of participants that achieved disease control 6 months after randomization. Best objective response of complete response + partial response + stable disease > 24 weeks according to RECIST criteria

  2. 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

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 <0.5 mU/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*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. Participants 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
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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
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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
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Study Chair: Clinical Sciences & Operations Sanofi
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00537095    
Other Study ID Numbers: D4200C00079
2007-001890-27 ( EudraCT Number )
LPS14940 ( Other Identifier: Sanofi )
First Posted: September 28, 2007    Key Record Dates
Results First Posted: July 8, 2011
Last Update Posted: April 19, 2024
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
follicular
papillary
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
 Neoplasms by Site
Neoplasms
Head and Neck Neoplasms