Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcia Brose, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00654238
First received: April 1, 2008
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

The goal of this study is to determine the activity of sorafenib in patients with advanced (metastatic or recurrent) thyroid cancer.


Condition Intervention Phase
Metastatic Differentiated Thyroid Cancer
Metastatic Poorly Differentiated Thyroid Cancer
Metastatic Anaplastic Thyroid Cancer
Metastatic Medullary Thyroid Cancer
Drug: sorafenib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • To determine the efficacy of BAY 43-9006 (objective response rate and stable disease) in patients with metastatic thyroid carcinoma. [ Time Frame: Months 2,4, and every three months therafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the secondary endpoints of best response, time to disease progression, and duration of response in patients receiving BAY 43-9006. [ Time Frame: Months 2,4, and every three months thereafter ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: February 2006
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
This is a single arm study.
Drug: sorafenib
400mg PO BID daily
Other Name: Nexavar (Bayer)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 treatment.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654238

Locations
United States, Pennsylvania
University of Pennsylvania - Abramson Comprehensive Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Marcia S Brose, MD PhD Unviersity of Pennsylvania - Abramson Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Marcia Brose, Associate Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00654238     History of Changes
Obsolete Identifiers: NCT00601783
Other Study ID Numbers: 802861, UPCC 03305
Study First Received: April 1, 2008
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Thyroid Cancer
Anaplastic
Medullary
sorafenib

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014