Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005542

Trial Description

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Title

A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Locally advanced or metastatic thyroid cancer treatment

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005542
  •   2014/08/21
  •   2009/09/24
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2009-012007-25 
  •   NCT00984282  (ClinicalTrials.gov)
  •   14295  (Bayer)
  •   2009-012007-25 
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Health Condition or Problem studied

  •   Thyroid Neoplasms
  •   C73 -  Malignant neoplasm of thyroid gland
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Interventions/Observational Groups

  •   Drug: Sorafenib (Nexavar, BAY43-9006)
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Progression-Free Survival (PFS); time frame: Radiologic tumor assessments will be done every 56 days (two cycles) during treatment

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Secondary Outcome

- Overall Survival (OS); time frame: Survival will be observed on a continuous basis
- Time to Progression (TTP); time frame: Radiologic tumor assessments will be done every 56 days (two cycles) during treatment
- Disease Control Rate (DCR); time frame: Radiologic tumor assessments will be done every 56 days (two cycles) during treatment
- Response rate; time frame: Radiologic tumor assessments will be done every 56 days (two cycles) during treatment
- Duration of response; time frame: Radiologic tumor assessments will be done every 56 days (two cycles) during treatment
- Exposure of Sorafenib (AUC (0-12)) by population pharmacokinetic methods; time frame: Cycle 2 (2 mos after the start of initial treatment) must have 14 day uninterrupted sorafenib dosing.
- Safety; time frame: From randomization until end of treatment; Safety will include assessment of adverse events and abnormalities in laboratory parameters.

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Countries of Recruitment

  •   United States
  •   Austria
  •   Belgium
  •   Bulgaria
  •   China
  •   Denmark
  •   France
  •   Germany
  •   Italy
  •   Japan
  •   Korea, Republic of
  •   Netherlands
  •   Poland
  •   Russian Federation
  •   Saudi Arabia
  •   Slovakia
  •   Spain
  •   Sweden
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2009/10/31
  •   419
  •   [---]*
  •   [---]*
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular
and Hurthle cell)

- Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are
eligible provided that the histology has no medullary differentiation nor anaplastic
features

- Progression within 14 months (RECIST should be used as a basis for the assessment of
disease progression)

- RAI (radioactive iodine) refractory

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Exclusion Criteria

- Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic
and medullary carcinoma, lymphoma or sarcoma)

- Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies
(licensed or investigational) that target VEGF (vascular endothelial growth factor)
or VEGF Receptors or other targeted agents

- Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose
chemotherapy for radiosensitization is allowed) or Thalidomide or any of its
derivatives

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Addresses

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    • Bayer
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    • Onyx Pharmaceuticals
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Bayer
    • Bayer Study Director 
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    •   [---]*
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    • Bayer
    • Bayer Study Director 
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.