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 : October 25, 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 2020|
|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.
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): 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|