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

This study has been completed.

First Received: April 22, 2009 No Changes Posted

Sponsored by:	Leiden University Medical Center
Information provided by:	Leiden University Medical Center
ClinicalTrials.gov Identifier:	NCT00887107

Purpose

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

Condition	Intervention	Phase
Thyroid Cancer	Drug: Sorafenib (nexavar)	Phase II

MedlinePlus related topics: Cancer Thyroid Cancer

Drug Information available for: Sorafenib Sorafenib tosylate Thyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Sorafenib as Adjuvant to Radioiodine Therapy in Non-Medullary Thyroid Carcinoma

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	October 2007

Arms	Assigned Interventions
sorafenib: Experimental 30 patients with non-radioiodine avid differentiated thyroid carcinoma	Drug: Sorafenib (nexavar) 6 months therapy with Sorafenib 800 mg/day

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887107

Locations

Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300 RC

Sponsors and Collaborators

Leiden University Medical Center

Investigators

Principal Investigator:

Johannes W Smit, MD, PhD

Leiden Universty Medical Center

More Information

No publications provided

Responsible Party:	leiden University Medical Center ( Johannes Smit, M.D., Ph.D. )
Study ID Numbers:	NL17727.058.07, P07.109
Study First Received:	April 22, 2009
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00887107 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Thyroid Neoplasms
Thyroid Cancer, Papillary
Head and Neck Neoplasms
Adjuvants, Immunologic
Endocrine System Diseases
Endocrinopathy

Protein Kinase Inhibitors
Sorafenib
Thyroid Diseases
Endocrine Gland Neoplasms
Carcinoma

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Thyroid Neoplasms
Antineoplastic Agents
Endocrine System Diseases
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Therapeutic Uses
Sorafenib
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009