Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
Doctors are running a large study to see if a new medicine called Tinengotinib can help people with a specific type of bile duct cancer, cholangiocarcinoma. This cancer must have certain genetic changes (called FGFR alterations) and must have already been treated with chemotherapy and another FGFR inhibitor drug, but without success or if the cancer has returned. The study will compare Tinengotinib at two different doses (8 mg and 10 mg) against treatments chosen by the patient's doctor. This is a Phase 3 study, which means it’s one of the final steps before a new medicine might become widely available. About 200 patients from around the world will take part, with the aim to find out how safe and effective Tinengotinib is.
במבט חטוף
על מה המחקר הזה?
This study is looking into a new medicine called Tinengotinib for a specific type of bile duct cancer, known as cholangiocarcinoma. The doctors are particularly interested in patients whose cancer has a special genetic change, called an 'FGFR alteration'. This change can sometimes make cancer cells grow and spread. If you have been diagnosed with this type of cancer and your previous treatments, including chemotherapy and a specific type of drug called an FGFR inhibitor, haven't worked or your cancer has come back, then this study might be for you.
The main goal is to find out if Tinengotinib is a safe and effective treatment. Researchers will compare it to what your doctor would normally choose as your next treatment. This is a 'Phase 3' study, which is a major step in testing new medicines. It means a larger number of patients globally will take part to get a clearer picture of the medicine's benefits and potential side effects.
In the study, some participants will receive Tinengotinib at either an 8 mg or 10 mg dose each day, while others will receive treatment chosen by their doctor. Around 200 people are expected to join the study. Doctors hope that Tinengotinib could offer a new option for patients with this form of cholangiocarcinoma who have limited treatment choices left.
נקודות עיקריות
- This study tests a new drug, Tinengotinib, for bile duct cancer with specific genetic changes.
- It's for patients whose cancer hasn't responded to previous chemotherapy and an FGFR inhibitor.
- The study compares Tinengotinib against standard treatments chosen by a doctor.
- It's a Phase 3 study, meaning it's a key step in evaluating a potential new cancer treatment.
- Around 200 patients worldwide will take part to assess the drug's safety and effectiveness.
מי עשוי להיות זכאי?
To be considered for this study, you must be 18 years or older. You need to have been diagnosed with cholangiocarcinoma (bile duct cancer) that has spread or can't be removed with surgery. Importantly, your cancer must have a specific genetic change called an 'FGFR2 fusion/rearrangement', and your doctors will need to confirm this. You must have already tried at least one type of chemotherapy and exactly one FDA-approved FGFR inhibitor medicine, but these treatments haven't worked well enough or your cancer has returned.
There are also some reasons why you might not be able to join. For example, if you've already had two or more FGFR inhibitor drugs, or if your cancer has spread to your brain and is getting worse quickly. You also can't have another type of cancer that is active and needs treatment, unless it's a very minor skin cancer or a specific type of cervical cancer. Doctors will also check that you've recovered from any serious side effects of your previous treatments before starting a new medicine in the study.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- האם אתה בן 18 או יותר?
- Do you have bile duct cancer (cholangiocarcinoma) that has spread or cannot be removed?
- Has your doctor confirmed your cancer has the 'FGFR2 fusion/rearrangement' genetic change?
- Have you already received at least one chemotherapy treatment?
- Have you already received exactly one specific type of drug called an FGFR inhibitor?
- Are you able to recover from side effects of previous treatments before starting a new one?
מה כרוך בהשתתפות?
If you join this study, you will be assigned to one of three groups. Two groups will receive Tinengotinib, either as an 8 mg tablet or a 10 mg tablet, once a day. The third group will receive a treatment chosen by your doctor. You won't be able to choose which group you are in, as this is decided randomly, like flipping a coin. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. The study will continue for as long as the treatment is helping you and you are tolerating it well. After you stop taking the study drug, there will be some follow-up appointments to check on your long-term health.
סיכונים ותועלות פוטנציאליים
מיקומים (87)
- UCLA Medical Centerמיקוד מאומתסנטה מוניקה, ארצות הברית
- מרכז הסרטן של סטנפורדמיקוד מאומתסטנפורד, ארצות הברית
- The University of Kansas Cancer Centerמיקוד מאומתWestwood, Los Angeles, United States
- Mount Sinai Comprehensive Cancer Centerמיקוד מאומתמיאמי ביץ', ארצות הברית
- The University of Chicago Hospitalsמיקוד מאומתשיקגו, ארצות הברית
- UMass Memorial Medical Centerמיקוד מאומתווסטר, ארצות הברית
- אוניברסיטת מישיגןמיקוד מאומתאן ארבור, ארצות הברית
- Henry Fordמיקוד מאומתדטרויט, ארצות הברית
- University of Minnesota- Masonic Cancer Center, M Health Fairviewמיקוד מאומתמיניאפוליס, ארצות הברית
- Roswell Park Comprehensive Cancer Centerמיקוד מאומתBuffalo, United States
- Messino Cancer Centersמיקוד מאומתAsheville, United States
- University Hospitals Cleveland Medical Centerמיקוד מאומתקליבלנד, ארצות הברית
שאלות נפוצות
What is 'cholangiocarcinoma'?
Cholangiocarcinoma is a type of cancer that forms in the bile ducts, which are tubes that carry bile from the liver.
What does 'FGFR-altered' mean?
'FGFR-altered' means that your cancer cells have a specific genetic change, or alteration, in something called the Fibroblast Growth Factor Receptor gene. This change can affect how the cancer grows.
מהו מחקר 'שלב 3'?
A Phase 3 study is a major step in testing new medicines. It involves a larger group of people and aims to confirm if a new treatment is safe and more effective than existing ones, before it can be approved for general use.
Will I get to choose my treatment?
No, in this study, the treatment you receive (either Tinengotinib or a doctor's choice treatment) will be decided randomly, meaning it's like a lottery or coin toss. This helps ensure the results are fair.
What happens after the study ends?
After you stop taking the study drug, you will have follow-up appointments to monitor your health. Your study doctor will discuss your continued care options with you.
כיצד לגלות עוד
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
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