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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary:

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 discreti

    Detailed Summary:
    Sponsor: Genzyme, a Sanofi Company

    Current Primary Outcome: 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


    Original Primary Outcome: To demonstrate an improvement in progression free survival (PFS) with ZACTIMA™ (ZD6474) 300 mg as compared to Placebo in subjects with locally advanced or metastatic papillary or follicular Thyroid Carcinoma failing or unsuitable for Radioiodine therapy

    Current Secondary Outcome:

    • 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.


    Original Secondary Outcome:

    Information By: Sanofi

    Dates:
    Date Received: September 27, 2007
    Date Started: September 2007
    Date Completion: December 2019
    Last Updated: October 7, 2016
    Last Verified: October 2016