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)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anaplastic Thyroid Cancer Recurrent Thyroid Cancer Drug: sorafenib tosylate Phase 2

Detailed Description:


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of BAY 43-9006 in Patients With Advanced Anaplastic Carcinoma of the Thyroid
Study Start Date : June 2005
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
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.
Drug: sorafenib tosylate
Given orally
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression. [ Time Frame: 27 months ]
  2. Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death. [ Time Frame: 27 months ]
  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00126568

United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Panayiotis Savvides Case Western Reserve University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00126568     History of Changes
Other Study ID Numbers: NCI-2009-00118
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 )
First Posted: August 4, 2005    Key Record Dates
Results First Posted: August 10, 2012
Last Update Posted: January 19, 2018
Last Verified: December 2017

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Thyroid Carcinoma, Anaplastic
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs