Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00126568
Recruitment Status : Terminated
First Posted : August 4, 2005
Results First Posted : August 10, 2012
Last Update Posted : January 19, 2018
Information provided by (Responsible Party):
National Cancer Institute (NCI)

August 2, 2005
August 4, 2005
May 23, 2012
August 10, 2012
January 19, 2018
June 2005
September 2011   (Final data collection date for primary outcome measure)
Number of Patients With Response to Treatment Measured by RECIST Criteria [ Time Frame: at 6 months after treatment ]
Response evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The patient's best response depends on the achievement of measurement and confirmation criteria of Complete Response (CR), Stable Disease (SD), Partial Response (PR) or Progressive Disease (PD). Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, x-ray) or as >10 mm with spiral CT scan.
Not Provided
Complete list of historical versions of study NCT00126568 on Archive Site
  • Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression. [ Time Frame: 27 months ]
  • Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death. [ Time Frame: 27 months ]
  • Number of Participants That Experienced Adverse Events to Characterize the Safety Profile of BAY 43-9006 [ Time Frame: 27 months ]
    The safety and toxicity profile of BAY 43-9006 as measured by toxicity grades of adverse events.
Not Provided
Not Provided
Not Provided
Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer
Phase II Trial of BAY 43-9006 in Patients With Advanced Anaplastic Carcinoma of the Thyroid
This phase II trial is studying how well sorafenib works in treating patients with advanced anaplastic thyroid cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.


I. Determine whether the objective response rate is ≥ 20% in patients with advanced anaplastic thyroid cancer treated with sorafenib.

II. Determine the survival of patients treated with this drug. III. Determine the safety profile of this drug in these patients. IV. Determine the pharmacokinetic predictors of response to this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for survival.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Anaplastic Thyroid Cancer
  • Recurrent Thyroid Cancer
Drug: sorafenib tosylate
Given orally
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: sorafenib tosylate
Savvides P, Nagaiah G, Lavertu P, Fu P, Wright JJ, Chapman R, Wasman J, Dowlati A, Remick SC. Phase II trial of sorafenib in patients with advanced anaplastic carcinoma of the thyroid. Thyroid. 2013 May;23(5):600-4. doi: 10.1089/thy.2012.0103. Epub 2013 Apr 18.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
September 2011
September 2011   (Final data collection date for primary outcome measure)


  • Progressive disease after prior cytotoxic chemotherapy (i.e., chemotherapy alone or combined with radiotherapy)
  • No symptomatic bulky disease that would impair the airway or impede swallowing (for patients with ECOG performance status 2)
  • No known brain metastases
  • Measurable or evaluable disease

    • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
    • Measurable disease not in a previously irradiated field
  • Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible provided disease has been stable for the past 6 months
  • Performance status:

    • ECOG 0-2 OR Karnofsky 50-100%
  • Life expectancy more than 8 weeks
  • Absolute neutrophil count >= 1,250/mm3
  • Platelet count >= 100,000/mm3
  • No evidence of bleeding diathesis
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • PTT =< 1.5 times ULN
  • Creatinine =< 1.5 times ULN
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV cardiac disease
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No uncontrolled hypertension (i.e., systolic blood pressure (BP) > 150 mm Hg OR diastolic BP > 100 mm Hg)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to swallow oral medication
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No other uncontrolled illness
  • No more than 2 prior systemic cytotoxic chemotherapy regimens (combined modality systemic cytoxic chemotherapy is considered 1 prior cytotoxic regimen)
  • At least 7 days since prior chemotherapy and recovered
  • At least 7 days since prior radiotherapy and recovered
  • No prior sorafenib or other inhibitors of MAP kinase signaling intermediates
  • No prior cancer treatment that would preclude study participation
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
  • No concurrent Hypericum perforatum (St. John's wort) or rifampin
  • No concurrent therapeutic anticoagulation (concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial access devices allowed provided requirements for INR and PTT are met)
  • No other concurrent anticancer therapy
  • Histologically confirmed anaplastic* thyroid cancer

    • Not amenable to definitive curative surgery or radiotherapy [Note: *Papillary, follicular, or other histologies that are mixed or identified in a diagnostic tissue sample are allowed provided a high-grade undifferentiated anaplastic component is present ]
  • No cardiac arrhythmia
  • AST and ALT =< 3.5 times ULN
  • INR < 2.0
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
NCI-2009-00118 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE 5304
CASE 5304 ( Other Identifier: Case Western Reserve University )
7037 ( Other Identifier: CTEP )
U01CA062502 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Panayiotis Savvides Case Western Reserve University
National Cancer Institute (NCI)
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP