Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer

Phase 2

Terminated

• Conditions: Anaplastic Thyroid Cancer; Recurrent Thyroid Cancer
• Interventions: Drug: sorafenib tosylate

• Registration Number: NCT00126568
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

This phase II trial is studying how well sorafenib works in treating patients with advanced anaplastic thyroid cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed Description

OBJECTIVES:

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-08-02
• Study First Submitted QC: 2005-08-02
• Study First Posted: 2005-08-04
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2012-05-23
• Results First Submitted QC: 2012-07-02
• Results First Posted: 2012-08-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (sorafenib tosylate)	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Response to Treatment Measured by RECIST Criteria	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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression.	27 months
Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death.	27 months
Number of Participants That Experienced Adverse Events to Characterize the Safety Profile of BAY 43-9006	27 months	The safety and toxicity profile of BAY 43-9006 as measured by toxicity grades of adverse events.

Trial Locations

Locations (1)

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States