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Ativo, mas não recrutandoFASE1INTERVENCIONISTA

A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma

This research study is for children and young adults, aged 2 to 21, who have neuroblastoma that has either returned after treatment or hasn't responded to previous therapies. The main goal is to test a new medicine named LY3295668 erbumine. We want to learn if this medicine is safe for patients and how their bodies react to it. Participants will take the medicine, and doctors will carefully monitor them for any side effects. This study aims to gather important information that could help develop new ways to treat neuroblastoma in the future. It's an early-stage study, meaning it's one of the first times this medicine is being tested in people.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE1
Patrocinador
Eli Lilly and Company
Meta de inscrição
71
Iniciar
11 de jun de 2020
Conclusão estimada
01 Ago 2027

Sobre o que é este estudo?

This study is focused on a type of cancer called neuroblastoma, which often affects young children. Sometimes, after initial treatments, neuroblastoma might come back (what doctors call 'relapsed') or it might not respond as well as hoped to existing treatments (known as 'refractory'). When this happens, we need to find new and effective ways to help.

That's where this study comes in. Researchers are investigating a new medicine called LY3295668 erbumine. The main purpose of this early study (called 'Phase 1') is to see if this new medicine is safe for young people with relapsed or refractory neuroblastoma. Doctors will give the medicine and watch carefully to see how patients respond and if there are any side effects. They'll also check to see what dose is safe.

The information gathered from studies like this is really important. It helps scientists understand how new medicines work and if they could potentially be helpful for patients in the future. It's a key step in developing better treatments and improving the lives of children and young adults facing neuroblastoma.

Pontos principais

  • This study is testing a new medicine for neuroblastoma that has come back or not responded to other treatments.
  • It's for children and young people aged 2 to 21.
  • The main goal is to see if the new medicine is safe.
  • Participants will take the medicine as capsules and have regular check-ups.
  • It's an early-stage study, meaning we are learning about this medicine for the first time in people.
  • Você pode parar de participar a qualquer momento.

Quem pode ser elegível?

To join this study, children and young people need to be between 2 and 21 years old and have neuroblastoma that has come back or hasn't responded to earlier treatments. The disease must be active in areas like their bones, bone marrow, or soft tissues. Participants also need to be able to swallow capsules, as the study medicine is taken this way.

There are also some reasons why someone might not be able to join. For example, if they've had certain types of transplants (like a stem cell or organ transplant), or if the neuroblastoma has spread to their brain or spinal cord without being treated. They also shouldn't have other serious illnesses, problems absorbing medicines, or a known allergy to any part of the study treatment. If they've taken similar medicines recently or have certain active infections like HIV or hepatitis, this would also mean they can't take part.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  1. Am I, or the person I care for, between 2 and 21 years old?
  2. Do I have neuroblastoma that has come back or not responded to previous treatments?
  3. Is the neuroblastoma currently active in my bone, bone marrow, or soft tissue?
  4. Am I able to swallow capsules?
  5. Have I had an organ or stem cell transplant?
  6. Do I have any other serious untreated diseases or active infections like HIV or hepatitis?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part in this study, you will be given the study medicine, LY3295668 erbumine, which you will take as capsules. You will need to attend regular appointments at the hospital. At these visits, doctors will perform examinations and tests, which might include blood tests and scans, to check on your health and how you are responding to the medicine. They will also carefully watch for any side effects you might experience. The exact number and frequency of visits will be explained by the study team. They will also tell you the total length of time you will be involved in the study.

Riscos e benefícios potenciais

Taking part in a study like this might offer a potential benefit by giving you access to a new medicine that isn't widely available yet, which could help with your neuroblastoma. However, it's also important to know that there are potential risks. The medicine might cause side effects, and we don't know the full extent of these yet, as it's a new treatment. The care team will explain all known and potential side effects to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Localizações (17)

  • UCSF Medical Center at Mission Bay
    Código postal verificado
    São Francisco, Estados Unidos
  • Children's Hospital Colorado
    Código postal verificado
    Aurora, Estados Unidos
  • University of Chicago - Comer Children's Hospital
    Código postal verificado
    Chicago, Estados Unidos
  • Instituto de Câncer Dana-Farber
    Código postal verificado
    Boston, Estados Unidos
  • Cincinnati Childrens Hospital Medical Center
    Código postal verificado
    Cincinnati, Estados Unidos
  • Hospital Infantil da Filadélfia
    Código postal verificado
    Filadélfia, Estados Unidos
  • Texas Childrens Hospital
    Código postal verificado
    Houston, Estados Unidos
  • Hospital Infantil de Perth
    Código postal verificado
    Perth, Australia
  • UZ Gent
    Código postal verificado
    Gante, Bélgica
  • Centre Leon Berard
    Código postal verificado
    Lyon, França
  • Institut Curie
    Código postal verificado
    Paris, França
  • Universitätsklinikum Köln
    Código postal verificado
    Colônia, Alemanha

Perguntas frequentes

O que é neuroblastoma?

Neuroblastoma is a type of cancer that often affects young children, starting in nerve tissue outside of the brain.

What does 'relapsed/refractory' mean?

This means the neuroblastoma has either come back after previous treatment, or it hasn't responded well to earlier treatments.

What is the new medicine being tested?

The new medicine is called LY3295668 erbumine. It's an early-stage medicine not yet widely available.

Will I get other cancer treatments during the study?

The study will focus on LY3295668 erbumine. Your doctor will discuss all your treatment options with you.

Quem está financiando esta pesquisa?

Clinical trials are typically funded by pharmaceutical companies, government agencies, or charitable organisations. Your doctor can provide specific funding details for this study.

Como saber mais

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

Discussão

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