Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
This clinical trial is investigating a new medication called futibatinib (also known as TAS-120) for people who have advanced bile duct cancer, specifically intrahepatic or extrahepatic cholangiocarcinoma. The study is for patients whose cancer has a particular genetic alteration known as an FGFR2 fusion or rearrangement. All participants in this study would have already received at least one course of standard chemotherapy, such as gemcitabine and platinum-based treatments. The main goal is to confirm how well futibatinib works at a 20 mg dose that has shown promise and to also explore a 16 mg dose. This is an open-label, international study, meaning both patients and their doctors will know which dose they are receiving. The study aims to look at both the effectiveness of the drug in shrinking or controlling the cancer and its safety.
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¿De qué trata este estudio?
This study is about a type of cancer that starts in the bile ducts, called cholangiocarcinoma. Bile ducts are small tubes that carry bile (a fluid that helps digest fats) from your liver to your small intestine. When this cancer is 'advanced', it means it has spread to other parts of the body or can't be removed with surgery.
Doctors have found that some people with cholangiocarcinoma have a specific change in their cancer cells called an FGFR2 fusion or rearrangement. This means that two genes (FGFR2 and another one) have joined together in a way they shouldn't, which can make the cancer grow. The drug being studied, futibatinib (also known as TAS-120), is designed to target and block the effects of this specific gene change. It's hoped that by doing this, the drug can help stop the cancer from growing or even shrink it.
This trial is looking at futibatinib in people who have already had other treatments for their advanced cholangiocarcinoma, such as chemotherapy, but whose cancer has continued to grow. The study will compare two different daily doses of futibatinib – 16 mg and 20 mg – to see which is more effective and safer. By studying this drug, researchers hope to find new ways to treat this type of cancer more effectively for people who have this particular genetic change.
Puntos clave
- This study is for advanced bile duct cancer with specific gene changes.
- It tests a new drug, futibatinib (TAS-120), at two different daily doses.
- Participants must have already tried standard chemotherapy.
- The drug aims to target a gene change called `FGFR2 fusion or rearrangement`.
- The goal is to find safer and more effective treatments for this type of cancer.
- You can stop participating at any time if you choose.
¿Quién puede ser elegible?
To be able to join this study, you would need to be an adult (18 years or older) with advanced cholangiocarcinoma that doctors have confirmed through a biopsy. An important part is that your cancer must have a specific change in its genes called an FGFR2 fusion or rearrangement. You also need to have already received at least one round of chemotherapy, like gemcitabine and platinum-based treatments, and unfortunately, your cancer would have shown signs of growing despite those treatments.
In addition, doctors would need to be able to measure your cancer on scans, which helps them track how well the treatment is working. You would also need to be generally well enough to take part, meaning you score 0 or 1 on a scale that measures your daily activity levels (known as a performance status). Your liver, kidney, and other organs would need to be working well enough.
There are also reasons why you might not be able to join. For example, if you have certain problems with your body's calcium and phosphate balance, or certain eye conditions. If you've had major surgery recently, or radiotherapy, or other cancer treatments within a specific timeframe before the study starts, you might also not be eligible. If you've had other drugs that target FGFR before, or have certain serious heart problems or active brain cancer spread, you likely wouldn't be able to participate.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- ¿Eres un adulto de 18 años o más?
- Have you been diagnosed with advanced bile duct cancer (cholangiocarcinoma)?
- Does your cancer have a confirmed `FGFR2` gene change?
- Have you already received at least one type of chemotherapy for your cancer?
- Are you generally well and able to carry out most daily activities?
- Do you have good overall organ function (liver, kidneys, etc.)?
¿En qué consiste la participación?
If you decide to take part in this study, you would be randomly assigned to receive one of two doses of futibatinib: either 16 mg or 20 mg. You would take this medication as a tablet by mouth, once every day. You would continue taking the drug every day during a 21-day cycle, and then start a new cycle. This treatment would continue for as long as the drug is helping to control your cancer and you are not experiencing severe side effects. You would have regular appointments for check-ups, blood tests, and scans to see how the cancer is responding to the treatment and to monitor for any side effects. The study involves continuous treatment until your disease worsens or if you need to stop for other reasons.
Riesgos y beneficios potenciales
Locations (65)
- University of California San Diego UCSD - Moores Cancer CenterCódigo postal verificadoLa Jolla, Estados Unidos· Reclutamiento
- Tampa General Hospital Cancer InstituteCódigo postal verificadoTampa, Estados Unidos· Reclutamiento
- Henry Ford Health SystemCódigo postal verificadoDetroit, Estados Unidos· Reclutamiento
- Gabrail Cancer Center ResearchCódigo postal verificadoCanton, United States· Retirado
- Texas OncologyCódigo postal verificadoAbilene, United States· Reclutamiento
- The Liver Institute at Methodist Dallas Medical CenterCódigo postal verificadoDallas, United States· Reclutamiento
- Texas Oncology Methodist DFWCódigo postal verificadoDallas, United States· Reclutamiento
- Texas Onc Methodist (Charlton)Código postal verificadoDallas, United States· Reclutamiento
- Texas Oncology - NortheastCódigo postal verificadoDenton, United States· Reclutamiento
- Center for Oncology and Blood DisordersCódigo postal verificadoHouston, Estados Unidos· Retirado
- Hospital BritanicoCódigo postal verificadoBuenos Aires, Argentina· Reclutamiento
- CEMICApproximateCABA, Argentina· Reclutamiento
Preguntas comunes
What is `advanced cholangiocarcinoma`?
It's a type of cancer that starts in the bile ducts, which are tubes in your liver. 'Advanced' means it has spread to other parts of the body or cannot be removed by surgery.
What is an `FGFR2 fusion or rearrangement`?
This is a specific change in the genes within your cancer cells. It means two genes have joined incorrectly, which can cause the cancer to grow. Futibatinib is designed to target this change.
What is `futibatinib (TAS-120)`?
Futibatinib is the name of the new experimental drug being studied. It's a type of 'targeted therapy' designed to block the effects of the `FGFR2` gene change in cancer cells.
Why are there two different doses of futibatinib?
The study aims to confirm the benefits of a 20 mg dose that has shown promise and also to check how safe and effective a slightly lower 16 mg dose is. This helps researchers find the best possible treatment.
What does `open-label` mean?
Open-label means that both you and your study doctor will know which dose of futibatinib you are receiving during the trial.
Cómo obtener más información
Taiho Oncology, INC
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.