check_circleStudy Completed

Thyroid Neoplasms

Bayer Identifier:

14295

ClinicalTrials.gov Identifier:

NCT00984282

EudraCT Number:

2009-012007-25

EU CT Number:

Not Available
Nexavar® versus Placebo in locally advanced/metastatic RAI-Refractory Differentiated Thyroid Cancer

Trial purpose

Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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 [Response Evaluation Criteria in Solid Tumors] should be used as a basis for the assessment of disease progression)
    - RAI (radioactive iodine) refractory
  • - 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

Trial summary

Enrollment Goal
417
Trial Dates
October 2009 - August 2017
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Erlangen, 91054, Germany
Completed
Essen, 45122, Germany
Completed
Leeds, LS9 7TF, United Kingdom
Completed
Newcastle Upon Tyne, NE7 7DN, United Kingdom
Completed
Cardiff, CF14 2TL, United Kingdom
Withdrawn
Nashville, 37232, United States
Completed
Boston, 02118, United States
Completed
Houston, 77030, United States
Completed
New Haven, 06520, United States
Completed
Pittsburgh, 15213-1863, United States
Withdrawn
Portland, 97239, United States
Completed
Ann Arbor, 48109, United States
Completed
Los Angeles, 90048, United States
Withdrawn
München, 80336, Germany
Completed
Würzburg, 97080, Germany
Completed
London, SM2 5PT, United Kingdom
Completed
London, SE1 9RT, United Kingdom
Completed
Manchester, M20 4BX, United Kingdom
Completed
St. Louis, 63110, United States
Withdrawn
Boston, 02115-6084, United States
Completed
Philadelphia, 19104, United States
Completed
Seattle, 98109-1023, United States
Completed
Stanford, 94305-5820, United States
Withdrawn
Columbus, 43210, United States
Completed
Albuquerque, 87106, United States
Completed
Atlanta, 30322, United States
Completed
BORDEAUX, 33076, France
Withdrawn
Charleston, 29425, United States
Completed
VILLEJUIF, 94805, France
Completed
LYON, 69373, France
Completed
PARIS, 75651, France
Completed
Poznan, 60-355, Poland
Completed
Siena, 53100, Italy
Completed
Milano, 20162, Italy
Completed
Perugia, 06126, Italy
Completed
Catania, 95029, Italy
Completed
Milano, 20122, Italy
Completed
Barcelona, 08035, Spain
Withdrawn
Zaragoza, 50009, Spain
Withdrawn
L'Hospitalet de Llobregat, 08907, Spain
Completed
Leiden, 2333 ZA, Netherlands
Completed
Göteborg, 413 45, Sweden
Completed
CAEN, 14076, France
Completed
MARSEILLE cedex, 13273, France
Completed
ANGERS, 49933, France
Completed
LILLE cedex, 59037, France
Completed
Warszawa, 04-141, Poland
Completed
Warszawa, 02-781, Poland
Completed
Gliwice, 44-101, Poland
Completed
Kashiwa, 277-8577, Japan
Completed
Nagoya, 464-8681, Japan
Completed
Koto-ku, 135-8550, Japan
Completed
Nagoya, 466-8560, Japan
Completed
Pisa, 56124, Italy
Completed
Napoli, 80131, Italy
Completed
Majadahonda, 28222, Spain
Withdrawn
Oviedo, 36328, Spain
Completed
Groningen, 9713 GZ, Netherlands
Completed
Lund, 221 85, Sweden
Completed
Odense C, 5000, Denmark
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Seoul, 135-710, Korea, Republic Of
Completed
Seoul, 120-752, Korea, Republic Of
Completed
Seoul, 110-744, Korea, Republic Of
Completed
Riyadh, 11211, Saudi Arabia
Completed
Linköping, 581 85, Sweden
Completed
Stockholm, 171 76, Sweden
Completed
Seoul, 137-701, Korea, Republic Of
Completed
Daejeon, 301-721, Korea, Republic Of
Completed
München, 81377, Germany
Completed
Köln, 50924, Germany
Completed
Leipzig, 04103, Germany
Completed
BRUXELLES - BRUSSEL, 1000, Belgium
Completed
Wien, 1090, Austria
Withdrawn
Linz, 4010, Austria
Completed
Shanghai, 200030, China
Completed
Guangzhou, 510060, China
Completed
Beijing, 100730, China
Completed
Beijing, 100021, China
Completed
Tianjin, 300060, China
Completed
chengdu, 610041, China
Completed
hangzhou, 310022, China
Completed
shanghai, 200127, China
Withdrawn
Wien, 1150, Austria
Completed
Obninsk, 249036, Russian Federation
Withdrawn
Barnaul, 656052, Russian Federation
Withdrawn
Berlin, 10117, Germany
Withdrawn
Verona, 37134, Italy
Completed
Milano, 20133, Italy
Completed
Sutton, SM2 5PT, United Kingdom
Completed
Aberdeen, AB25 2ZN, United Kingdom
Withdrawn
Verona, 37124, Italy
Completed
Glasgow, G12 0YN, United Kingdom
Completed
Genova, 16132, Italy
Withdrawn
Sofia, 1756, Bulgaria
Completed
Sofia, 1527, Bulgaria
Completed
New York, 10029, United States
Withdrawn
Bratislava, 812 50, Slovakia

Primary Outcome

  • Progression-free survival (PFS) based on central assessment incl. clinical progression due to bone irradiation
    date_rangeTime Frame:
    Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall survival (OS)
    date_rangeTime Frame:
    From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eighty ears
    enhanced_encryption
    Safety Issue:
    No
  • Time to progression (TTP) based on central assessment incl. clinical progression due to bone irradiation
    date_rangeTime Frame:
    From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
    enhanced_encryption
    Safety Issue:
    No
  • Disease control rate (DCR) based on central assessment incl. clinical progression due to bone irradiation
    date_rangeTime Frame:
    From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
    enhanced_encryption
    Safety Issue:
    No
  • Response rate based on central assessment incl. clinical progression due to bone irradiation
    date_rangeTime Frame:
    From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
    enhanced_encryption
    Safety Issue:
    No
  • Duration of response (DOR) based on central assessment
    date_rangeTime Frame:
    From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
    enhanced_encryption
    Safety Issue:
    No
  • Maximum percent reduction in target lesion size based on central assessment
    date_rangeTime Frame:
    From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-12h),ss (area under the concentration time curve from time 0 to 12 hours at steady state)
    date_rangeTime Frame:
    A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe