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Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Cancer

Phase 2
18 Years
Open (Enrolling)
Metastatic Differentiated Thyroid Cancer, Metastatic Poorly Differentiated Thyroid Cancer, Metastatic Anaplastic Thyroid Cancer, Metastatic Medullary Thyroid Cancer

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Trial Information

Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Cancer

Inclusion Criteria:

- Patients must have histologically confirmed thyroid cancer that is metastatic or
unresectable and for which standard curative or palliative measures do not exist or
are no longer effective.

- Patients may have received multiple treatments of radioactive iodine, one prior
biologic treatment, and at least half of the patients will have had no prior
chemotherapy for metastatic disease. At least 3 weeks must have elapsed since prior

- Measurable disease defined as at least one malignant lesion that can be accurately
and serially measured in at least one dimension (longest diameter to be recorded),
using a caliper (diameter > 10 mm) for superficial cutaneous disease, or using
contrast-enhanced CT or spiral CT (diameter > 20 mm) for visceral or nodal/soft
tissue disease.

- ECOG performance status < 2 (Appendix 1).

- Life expectancy greater than 3 months.

- Adequate organ function that has been determined within 7 days prior to enrollment,
defined as:Leucocyte count > 3,000/uL; Absolute neutrophil count (ANC) > 1,500/mm3,
platelets > 100,000/mm3, and hemoglobin > 9 g/dl; Serum creatinine < 1.5 times ULN,
or 24-hour creatinine clearance > 75 cc/min. (Note: creatinine clearance need not be
determined if the baseline serum creatinine is within normal limits); Serum bilirubin
< 1.5 times ULN; serum glutamyloxaloacetic transaminase (SGOT) < 2.5 ULN; alkaline
phosphatase < 2.5 times ULN; PT-INR/PTT < 1.5 x upper limit of normal.

- Intellectual, emotional, and physical ability to comply with oral medication.

- Ability to understand and the willingness to sign a written informed consent

- Patients with disease accessible for biopsy will be preferentially selected for
participation in the study. Accessible disease includes lymph node metastases.

- Female patients of child-bearing potential must have a negative pregnancy test within
14 days before initiation of study drug dosing. Post-menopausal women must be
amenorrheic for at least 12 months to be considered non-child-bearing potential.
Male and female patients of reproductive potential must agree to use adequate
contraception (i.e. hormonal or barrier method of birth control). throughout the
study and for 3 months after the study.

Exclusion Criteria:

- Significant medical disease including: uncontrolled congestive heart failure; active
symptoms of coronary artery disease, uncontrolled seizure disorder; active infection;
uncontrolled diabetes mellitus; requirement for chronic corticosteroid treatment;
requirement for concurrent immunosuppressive drug(s); active autoimmune disease.

- Organ allografts.

- Known HIV-infection (HIV testing is not required for participation).

- Pregnancy or lactation. Women of childbearing potential and sexually active males
must be advised to take precautions to prevent pregnancy during treatment

- History of second cancer (except adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, or other cancer for which the patient has been
disease-free for five or more years).

- Use of any experimental therapy within 3 weeks prior to baseline evaluations done
prior to enrollment.

- Patients with carcinomatous meningitis are excluded from the study.

- Excluded therapies and medications, previous and concomitant:Anticancer chemotherapy
or immunotherapy during the study or within 4 weeks prior to the first dose of the
study drug; Radiotherapy for the treatment of a symptomatic (e.g. bone metastasis) as
clinically indicated is allowed as long as it is not evidence of progressive disease
(see 4.5.2); -Biological response modifiers, such as G-CSF, within 3 week prior to
study entry. (G-CSF and other hematopoietic growth factors may be used in the
management of acute toxicity such as febrile neutropenia when clinically indicated or
at the discretion of the investigator; however they may not be substituted for a
required dose reduction); Patients taking chronic erythropoietin are permitted
provided no dose adjustment is undertaken within 2 months prior to the study or
during the study; Investigational drug therapy outside of this trial during or within
4 weeks prior the screening assessment; Use of ketoconazole, itraconazole, and
ritonavir; Use of carbamazepine, phenytoin, phenobarbital; Previous exposure to a Ras
pathway inhibitor (including herceptin, EGFr inhibitors, farnesyl transferase
inhibitors or MEK inhibitors); Use of grapefruit juice products; Use of cyclosporin;

- Pregnant or breast feeding.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the efficacy of BAY 43-9006 (objective response rate and stable disease) in patients with metastatic thyroid carcinoma.

Outcome Time Frame:

Months 2,4, and every three months therafter

Safety Issue:


Principal Investigator

Marcia S Brose, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Unviersity of Pennsylvania - Abramson Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Metastatic Differentiated Thyroid Cancer
  • Metastatic Poorly Differentiated Thyroid Cancer
  • Metastatic Anaplastic Thyroid Cancer
  • Metastatic Medullary Thyroid Cancer
  • Thyroid Cancer
  • Anaplastic
  • Medullary
  • sorafenib
  • Thyroid Neoplasms
  • Thyroid Diseases



University of Pennsylvania - Abramson Comprehensive Cancer Center Philadelphia, Pennsylvania  19104