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Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Onyx Pharmaceuticals
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00984282
First received: September 24, 2009
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

Locally advanced or metastatic thyroid cancer treatment


Condition Intervention Phase
Thyroid Neoplasms
 Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Radiologic tumor assessments will be done every 56 days (two cycles) during treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Survival will be observed on a continuous basis ] [ Designated as safety issue: No ]
  • Time to Progression (TTP) [ Time Frame: Radiologic tumor assessments will be done every 56 days (two cycles) during treatment ] [ Designated as safety issue: No ]
  • Disease Control Rate (DCR) [ Time Frame: Radiologic tumor assessments will be done every 56 days (two cycles) during treatment ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Radiologic tumor assessments will be done every 56 days (two cycles) during treatment ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Radiologic tumor assessments will be done every 56 days (two cycles) during treatment ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: From randomization until end of treatment ] [ Designated as safety issue: Yes ]
    Safety will include assessment of adverse events and abnormalities in laboratory parameters.


Enrollment: 419
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).
Placebo Comparator: Arm 2 Drug: Placebo
Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984282

  Show 98 Study Locations
Sponsors and Collaborators
Bayer
Onyx Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided by Bayer

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

Responsible Party: Therapeutic Area Head, Bayer HealthCare Paharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT00984282     History of Changes
Other Study ID Numbers: 14295, 2009-012007-25
Study First Received: September 24, 2009
Last Updated: March 13, 2013
Health Authority: China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Saudi Arabia: Ministry of Health
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Medical Products Agency
United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines
Austria: Agency for Health and Food Safety

Keywords provided by Bayer:
RAI-Refractory
Differentiated
Follicular
Papillary
Hurthle

Additional relevant MeSH terms:
Neoplasms
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
 Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013