A Phase 1 Study of LY5830966 in Participants With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)
This study is looking into a new medication called AJ1-11095. It's for adults with myelofibrosis, which includes Primary Myelofibrosis (PMF), Post-Essential Thrombocythemia Myelofibrosis (PET-MF), or Post-Polycythemia Vera Myelofibrosis (PPV-MF). Specifically, it's for those whose previous treatment with a JAK2 inhibitor medication hasn't worked as well as hoped or has stopped working. This first phase of the study aims to understand if the new drug is safe, what side effects it might cause, and how much of it the body can handle. Researchers will also look at how the drug works in the body and if it helps improve the condition.
De un vistazo
¿De qué trata este estudio?
This research study is about testing a new drug called AJ1-11095. It's designed for people who have a blood cancer called myelofibrosis. Myelofibrosis can be primary (meaning it starts on its own) or it can develop after other conditions like polycythemia vera or essential thrombocythemia.
Many people with myelofibrosis are treated with a type of medication called a JAK2 inhibitor. This study is for those whose current JAK2 inhibitor treatment hasn't been effective enough or has stopped working. The main goal is to find out if AJ1-11095 is safe and what the best dose is. The study will start with very small doses and gradually increase them to find a dose that is well-tolerated while also showing effects on the disease.
Because this is a very early-stage study (called Phase 1), it's the first time this specific drug is being given to people. Researchers will be paying close attention to any side effects and how the drug affects the body. They will also collect information to see if the drug shows any promise in helping with myelofibrosis symptoms.
Puntos clave
- This study is for adults with specific types of myelofibrosis.
- It's for people whose previous JAK2 inhibitor treatment is no longer working well.
- The new drug being tested is called AJ1-11095.
- This is an early-stage (Phase 1) study focused on safety and finding the best dose.
- Participation involves taking the study drug and regular hospital/clinic visits.
¿Quién puede ser elegible?
This study is looking for adults aged 18 or older who have been diagnosed with a specific type of myelofibrosis (Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis). Your myelofibrosis should be considered moderate to high risk, and your spleen must be enlarged. You also need to be experiencing certain symptoms related to your condition.
Crucially, you must have tried at least one other JAK2 inhibitor drug in the past, but it either didn't work well enough for you, or it stopped working. There are also specific requirements for your blood counts (like white blood cells called ANC, and platelets), kidney function, and liver function to make sure you are healthy enough to take part. Your heart rhythm will also be checked.
However, you won't be able to join if you've had your spleen removed or received radiation to your spleen recently. You also can't be pregnant or breastfeeding. Other reasons you might not be able to participate include having certain uncontrolled infections, specific types of hepatitis, or if you need to take certain medications that might interfere with the study drug.
¿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.
- ¿Tienes 18 años o más?
- Do you have a diagnosis of Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis?
- Has your prior JAK2 inhibitor treatment either stopped working or not been effective enough?
- Do you currently have an enlarged spleen and certain symptoms of myelofibrosis?
- ¿No estás embarazada o amamantando?
¿En qué consiste la participación?
If you join this study, you will take the study medication, AJ1-11095, by mouth. At first, you will have frequent visits to the study hospital or clinic so the doctors can carefully monitor how you are doing, check for any side effects, and see how your body handles the drug. This will involve blood tests, physical exams, and possibly scans to check your spleen size.
The study will start with a small group of participants and gradually increase the dose of the drug. Once a suitable dose is found, more people might join that dose group. You will continue to have regular check-ups throughout the study to make sure the drug is safe and to see if it is helping with your condition. The total length of your participation will depend on how you respond to the treatment and the study progress, but it will involve ongoing follow-up.
Riesgos y beneficios potenciales
Locations (21)
- Stanford Cancer InstituteCódigo postal verificadoPalo Alto, Estados Unidos· Reclutamiento
- Moffitt Cancer Cancer CenterCódigo postal verificadoTampa, Estados Unidos· Reclutamiento
- Centro Médico de la Universidad de KansasCódigo postal verificadoKansas City, Estados Unidos· Reclutamiento
- Hospital General de MassachusettsCódigo postal verificadoBoston, Estados Unidos· Reclutamiento
- Dana Farber Cancer InstituteCódigo postal verificadoBoston, Estados Unidos· Reclutamiento
- University of MichiganCódigo postal verificadoAnn Arbor, Estados Unidos· Reclutamiento
- Washington University School of MedicineCódigo postal verificadoSan Luis, Estados Unidos· Reclutamiento
- David H. Koch Center for Cancer Care at Memorial Sloan KetteringCódigo postal verificadoNueva York, Estados Unidos· Reclutamiento
- Escuela de Medicina Icahn en Mount SinaiCódigo postal verificadoNueva York, Estados Unidos· Reclutamiento
- Levine Cancer InstituteCódigo postal verificadoCharlotte, United States· Reclutamiento
- University of CincinnatiCódigo postal verificadoCincinnati, Estados Unidos· Reclutamiento
- The Ohio State University Comprehensive Cancer CenterCódigo postal verificadoColumbus, Estados Unidos· Reclutamiento
Preguntas comunes
¿Qué es la mielofibrosis?
Myelofibrosis is a condition where scar tissue builds up in the bone marrow, affecting how your body makes blood cells. This can lead to issues like anaemia, an enlarged spleen, and tiredness.
What is a 'JAK2 inhibitor'?
JAK2 inhibitors are a type of medication used to treat myelofibrosis. They work by blocking a protein called JAK2, which is often overactive in people with myelofibrosis.
What does 'Phase 1' mean for a study?
A Phase 1 study is the first step in testing a new drug in people. It mainly focuses on safety, finding the right dose, and understanding how the drug behaves in the body, rather than how well it treats the disease.
Will I know if I am getting the new drug?
This study is 'open-label,' which means both you and the study doctors will know that you are receiving the new drug, AJ1-11095. There isn't a placebo group in this study.
¿Cuánto tiempo estaré en el estudio?
The exact length of your participation will depend on how you respond to the treatment and the overall progress of the study. Your study doctor will discuss this with you in more detail.
Cómo obtener más información
David Steensma, M.D.
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
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