A Study Using Regorafenib as Second or Third Line Therapy in Metastatic Medullary Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT02657551|
Recruitment Status : Recruiting
First Posted : January 18, 2016
Last Update Posted : March 14, 2019
This research study is studying a targeted therapy as a possible treatment for thyroid cancer. A targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells.
- The name of the study intervention involved in this study is regorafenib.
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer||Drug: Regorafenib||Phase 2|
This is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has approved regorafenib as a treatment for metastatic colorectal cancer and locally advanced, unresectable or metastatic gastrointestinal stromal tumor. Regorafenib has not been approved for treatment against thyroid cancer.
Regorafenib is an oral anti-tumor agent that blocks activity of a specific kind of protein involved in normal cellular functions and in pathologic processes such as tumor formation and maintenance.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Using Regorafenib as Second or Third Line Therapy in Metastatic Medullary Thyroid Cancer|
|Actual Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||October 2022|
Regorafenib tablets orally, once daily at predetermined dosage for 21 days per cycle
Regorafenib is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes.
Other Name: Stivarga
- Response and Progression-free survival [ Time Frame: 10 Months ]Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).
- Safety variables - AEs, laboratory changes, changes in vital signs and ECG and, changes in chest x-ray images, at the investigator's discretion (e.g., for evaluation for pneumonia). [ Time Frame: 2 Years ]Safety variables include the following: AEs, laboratory changes, changes in vital signs and ECG and, in some instances, changes in chest x-ray images, as produced at the investigator's discretion
- Radiographic response [ Time Frame: 2 Years ]Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes will be used per the RECIST 1.1 criteria.
- Biomarkers associated with response [ Time Frame: 2 Years ]Whole exome sequencing will be performed on tumor and normal genomic DNA on all responders.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657551
|Contact: Jochen Lorch, MD||617-632-3090||JLORCH@partners.org|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Jochen Lorch, MD 617-632-3090 firstname.lastname@example.org|
|Principal Investigator: Jochen Lorch, MD|
|Principal Investigator:||Jochen Lorch, MD||Dana-Farber Cancer Institute|