Not recruitingRare disease

Study of LY3295668 Erbumine for Patients with Relapsed or Refractory Neuroblastoma

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called Neuroblastoma, which often affects children and can be difficult to treat if it comes back or does not respond to initial treatments. The study is testing a new treatment called LY3295668 Erbumine, which is an experimental drug designed to target and inhibit a specific protein involved in cancer cell growth. The drug is taken in the form of a capsule.

The purpose of the study is to determine the best dose of LY3295668 Erbumine when used alone or in combination with other treatments, by assessing its safety and how well it is tolerated by patients. Participants in the study will receive the medication and be monitored for any side effects or changes in their condition. The study aims to see how the drug affects the tumors in patients with relapsed or refractory neuroblastoma, meaning the cancer has returned or is resistant to treatment.

Throughout the study, participants will be closely observed to ensure their safety, and researchers will collect data on how the drug impacts the cancer and the overall health of the participants. The study will help determine if LY3295668 Erbumine can be a viable treatment option for neuroblastoma in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant must have relapsed or refractory neuroblastoma with active disease in at least one site: bone, bone marrow, or soft tissue.
The participant must be able to submit an archival sample of tissue and be capable of swallowing capsules.
Step 2
Medication administration
The participant will receive the medication LY3295668 Erbumine, which is an Aurora Kinase A Inhibitor.
The medication is administered in the form of a capsule and is taken orally.
Step 3
Treatment phase
The study aims to determine the recommended dose for Phase 2 by analyzing safety and tolerability.
The activity of LY3295668 on tumors will be evaluated in patients with recurrent or refractory neuroblastoma.
Step 4
Monitoring and evaluation
The primary endpoints include monitoring for dose-limiting toxicity and safety, which covers treatment-emergent adverse events, serious adverse events, deaths, and clinical laboratory abnormalities.
The overall response rate and overall survival will also be assessed.
Step 5
Study duration
The estimated end date for the study is August 25, 2025.
The recruitment for the study began on June 11, 2020.

Who can join the trial?

5 criteria

Participants must have a type of cancer called neuroblastoma that has come back or is not responding to treatment. The cancer must be active in at least one area such as the bones, bone marrow, or soft tissue.
Participants must be able to provide a sample of tissue from a previous test or surgery.
Participants must be able to swallow capsules.
Participants can be of any gender.
Participants must be between the ages of 2 and 18 years old.

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Verified sites

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Hospital Vall d’Hebron
Verified
Barcelona, Spain

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Investigated drugs

LY3295668 Erbumine is an experimental medication being studied for its potential to treat neuroblastoma, a type of cancer that occurs in certain types of nerve tissue. This medication works by inhibiting Aurora Kinase A, an enzyme that plays a role in cell division. By blocking this enzyme, LY3295668 Erbumine may help stop the growth of cancer cells. The study aims to determine the appropriate dose for future trials and to evaluate how effective the medication is in shrinking or controlling tumors in patients whose neuroblastoma has returned or is not responding to other treatments.

(2R,4R)-1-(3-Chloro-2-Fluorobenzyl)-4-((3-Fluoro-6-((5-Methyl-1H-Pyrazol-3-Yl)Amino)Pyridin-2-Yl)Methyl)-2-Methylpiperidine-4-Carboxylic Acid

What is already known about the treatment

LY3295668 Erbumine – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory neuroblastoma, a type of cancer that occurs in nerve tissue. It is in the investigational stage, meaning it is not yet approved for general medical use but is being evaluated for safety and effectiveness. The main therapeutic indication is for neuroblastoma, particularly in cases where the disease has returned or is resistant to standard treatments. LY3295668 Erbumine works by inhibiting Aurora Kinase A, a protein that plays a crucial role in cell division, thereby potentially stopping the growth of cancer cells. It is classified as an Aurora Kinase inhibitor in pharmacology.

Investigated diseases

Neuroblastoma – Neuroblastoma is a type of cancer that most commonly affects children and arises from immature nerve cells found in several areas of the body. It typically begins in the adrenal glands, which are located on top of the kidneys, but can also develop in the neck, chest, abdomen, or spine. The disease can spread to other parts of the body, including lymph nodes, bones, bone marrow, liver, and skin. Symptoms may vary depending on the location of the tumor and can include abdominal pain, a lump in the abdomen, or changes in bowel habits. As the disease progresses, it may cause fatigue, loss of appetite, and weight loss. Neuroblastoma is considered a rare disease and its progression can vary significantly from one individual to another.