Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT00126568|
Recruitment Status : Terminated
First Posted : August 4, 2005
Results First Posted : August 10, 2012
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anaplastic Thyroid Cancer Recurrent Thyroid Cancer||Drug: sorafenib tosylate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of BAY 43-9006 in Patients With Advanced Anaplastic Carcinoma of the Thyroid|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: sorafenib tosylate
- Number of Patients With Response to Treatment Measured by RECIST Criteria [ Time Frame: at 6 months after treatment ]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.
- Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression. [ Time Frame: 27 months ]
- Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death. [ Time Frame: 27 months ]
- Number of Participants That Experienced Adverse Events to Characterize the Safety Profile of BAY 43-9006 [ Time Frame: 27 months ]The safety and toxicity profile of BAY 43-9006 as measured by toxicity grades of adverse events.
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 ClinicalTrials.gov identifier (NCT number): NCT00126568
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Panayiotis Savvides||Case Western Reserve University|