Study on Using Regorafenib as a Second or Third Treatment Option for Advanced Medullary Thyroid Cancer
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT02657551
This clinical trial is exploring the use of regorafenib, a targeted therapy, as a potential treatment for patients with advanced medullary thyroid cancer who have already tried other treatments.
Patient Parameters
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Program Overview
This study is testing regorafenib, a targeted therapy, to see if it can help treat advanced medullary thyroid cancer. Targeted therapies are designed to attack specific cancer cells while causing less harm to normal cells. Regorafenib is already approved for other types of cancer but not yet for thyroid cancer. This trial aims to find out if it can be effective for this type of cancer as well.
Description
This is a Phase II clinical trial, which means it is testing the safety and effectiveness of regorafenib for treating advanced medullary thyroid cancer. Regorafenib is a medication taken by mouth that works by blocking certain proteins involved in cancer growth. While it is approved for other cancers, this study will determine if it can also help patients with thyroid cancer. Participants will be monitored to see how well the treatment works and if there are any side effects.
Eligibility Criteria
Inclusion Criteria
- Must be able to understand and sign a consent form.
- Age 18 or older.
- Expected to live at least 3 more months.
- Good overall health with a performance status of 0 or 1.
- Confirmed diagnosis of advanced medullary thyroid cancer.
- Cancer must have progressed within the last 6 months.
- Must have at least one measurable tumor.
- Must provide a tumor sample for testing.
- Can have had any number of previous treatments, but must have tried at least one targeted therapy.
- Must have good bone marrow, liver, and kidney function based on specific blood tests.
- Women of childbearing age must have a negative pregnancy test and use effective birth control.
- Must be able to swallow pills.
Exclusion Criteria
- Previous treatment with regorafenib.
- Uncontrolled high blood pressure.
- Significant heart disease or recent heart attack.
- History of severe bleeding or blood clotting disorders.
- Recent other cancers, except for certain skin or cervical cancers.
- Active infections like HIV or hepatitis.
- Brain tumors causing symptoms.
- Recent major surgery or injury.
- Pregnant or breastfeeding women.
- Any condition that makes participation unsafe or unsuitable.
- Use of certain medications or treatments that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale Cancer Center | 06520-8028 | New Haven | Connecticut |
| Dana-Farber Cancer Institute | 02115 | Boston | Massachusetts |
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