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.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
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.
النقاط الرئيسية
- 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.
من قد يكون مؤهلاً؟
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.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- هل عمرك 18 سنة أو أكثر؟
- 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?
ماذا يتضمن المشاركة؟
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.
المخاطر والفوائد المحتملة
Locations (87)
- مركز UCLA الطبيالرمز البريدي المؤكدسانتا مونيكا، الولايات المتحدة
- Stanford Cancer Centerالرمز البريدي المؤكدستانفورد، الولايات المتحدة
- مركز جامعة كانساس للسرطانالرمز البريدي المؤكدWestwood, Los Angeles, United States
- مركز ماونت سيناي الشامل للسرطانالرمز البريدي المؤكدميامي بيتش، الولايات المتحدة
- The University of Chicago Hospitalsالرمز البريدي المؤكدشيكاغو، الولايات المتحدة
- UMass Memorial Medical Centerالرمز البريدي المؤكدوورسيستر، الولايات المتحدة
- University of Michiganالرمز البريدي المؤكدآن آربر، الولايات المتحدة
- Henry Fordالرمز البريدي المؤكدديترويت، الولايات المتحدة
- University of Minnesota- Masonic Cancer Center, M Health Fairviewالرمز البريدي المؤكدمينيابوليس، الولايات المتحدة
- مركز روزويل بارك الشامل للسرطانالرمز البريدي المؤكدبوفالو، الولايات المتحدة
- Messino Cancer Centersالرمز البريدي المؤكدAsheville, United States
- مركز جامعة مستشفيات كليفلاند الطبيالرمز البريدي المؤكدكليفلاند، الولايات المتحدة
أسئلة شائعة
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.
ما هي دراسة 'المرحلة 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.
هل سأتمكن من اختيار علاجي؟
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.
ماذا يحدث بعد انتهاء الدراسة؟
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.
كيفية معرفة المزيد
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
نقاش
مناقشة المجتمع
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