Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Thyroid Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Time Frame:

Radiologic tumor assessments will be done every 56 days (two cycles) during treatment

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

China: Food and Drug Administration

Study ID:

14295

NCT ID:

NCT00984282

Start Date:

October 2009

Completion Date:

December 2013

Related Keywords:

  • Thyroid Neoplasms
  • RAI-Refractory
  • Differentiated
  • Follicular
  • Papillary
  • Hurthle
  • Neoplasms
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location

New Britain, Connecticut  06052
Albany, Georgia  31701
Fountain Valley, California  92708
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Albuquerque, New Mexico  87131-5636
Boston, Massachusetts  
Eugene, Oregon  
Charleston, South Carolina