Sorafenib as Adjuvant to Radioiodine Therapy in Non-Medullary Thyroid Carcinoma

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: NCT00887107
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : April 23, 2009
Information provided by:
Leiden University Medical Center

Brief Summary:
The purpose of this study is to assess whether therapy with Sorafenib reinduces radioiodine uptake in thyroid carcinoma.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Drug: Sorafenib (nexavar) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sorafenib as Adjuvant to Radioiodine Therapy in Non-Medullary Thyroid Carcinoma
Study Start Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: sorafenib
30 patients with non-radioiodine avid differentiated thyroid carcinoma
Drug: Sorafenib (nexavar)
6 months therapy with Sorafenib 800 mg/day
Other Name: nexavar

Primary Outcome Measures :
  1. Proportion of patients with a favorable response to Sorafenib defined as ONE OR MORE of the following criteria: 1. Reinduction of RaI uptake by RaI scintigraphy. 2. Serum thyroglobulin levels. 3. RECIST criteria [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with non-medullary thyroid carcinoma
  • The patients must have undergone total thyroidectomy
  • Presence of metastases or inoperable recurrent disease, as proven by elevated serum thyroglobulin levels (Tg) in combination with radiological evidence for tumor
  • No or insufficient RaI uptake in tumor as proven by RaI scintigraphy, performed after prior RaI therapy

Exclusion Criteria:

  • Pregnancy
  • Other active malignancies
  • Active kidney, liver or pancreatic disease or dysfunction
  • Unstable angina pectoris or recent (<3 months) myocardial infarction.
  • Coagulopathy

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): NCT00887107

Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Sponsors and Collaborators
Leiden University Medical Center
Principal Investigator: Johannes W Smit, MD, PhD Leiden Universty Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Johannes Smit, M.D., Ph.D., leiden University Medical Center Identifier: NCT00887107     History of Changes
Other Study ID Numbers: NL17727.058.07
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
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