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Phase II Trial of BAY 43-9006 in Patients With Advanced Anaplastic Carcinoma of the Thyroid

Phase 2
18 Years
Not Enrolling
Anaplastic Thyroid Cancer, Recurrent Thyroid Cancer

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Trial Information

Phase II Trial of BAY 43-9006 in Patients With Advanced Anaplastic Carcinoma of the Thyroid


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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With Response to Treatment Measured by RECIST Criteria

Outcome Description:

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.

Outcome Time Frame:

at 6 months after treatment

Safety Issue:


Principal Investigator

Panayiotis Savvides

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Western Reserve University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

Related Keywords:

  • Anaplastic Thyroid Cancer
  • Recurrent Thyroid Cancer
  • Thyroid Neoplasms
  • Thyroid Diseases
  • Carcinoma



Case Western Reserve University Cleveland, Ohio  44106