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(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

This article discusses a Phase 1 clinical trial investigating the use of LY3295668 Erbumine, an Aurora Kinase A inhibitor, in patients with relapsed or refractory neuroblastoma. The study aims to determine the recommended Phase 2 dose of the drug, both as a single agent and in combination therapy, while evaluating its safety, tolerability, and potential effectiveness against neuroblastoma tumors.

Table of Contents

What is LY3295668 Erbumine?

LY3295668 Erbumine is a new drug being studied for the treatment of relapsed or refractory neuroblastoma. It is also known by its chemical name, which is quite long and complex: (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.[1]

This medication is classified as an Aurora Kinase A inhibitor. Aurora Kinase A is a protein that plays a role in cell division. By inhibiting this protein, LY3295668 Erbumine may help slow down or stop the growth of cancer cells.[1]

Target Condition: Relapsed or Refractory Neuroblastoma

Neuroblastoma is a type of cancer that develops from immature nerve cells. It usually occurs in young children and is often found in and around the adrenal glands. When a neuroblastoma is described as “relapsed,” it means the cancer has come back after initial treatment. “Refractory” means the cancer has not responded well to treatment.[1]

Clinical Trial Details

A clinical trial (identified as J1O-MC-JZHD) is currently underway to study LY3295668 Erbumine. This is a Phase 1 study, which means it’s one of the earliest stages of testing a new drug in humans. The main goals of this study are to:[1]

  • Determine the right dose of LY3295668 Erbumine to use
  • Study how safe the drug is
  • Look at how well it works against neuroblastoma tumors

Eligibility Criteria

To participate in this study, patients must meet certain criteria. Here are some key points:[1]

Inclusion Criteria:

  • Patients must have relapsed or refractory neuroblastoma with active disease in at least one site (bone, bone marrow, or soft tissue)
  • Patients must be able to swallow capsules
  • Patients must be able to provide a tissue sample from their tumor

Exclusion Criteria:

  • Patients who have had certain types of transplants (allogeneic hematopoietic stem cell, bone marrow, or solid organ)
  • Patients with untreated tumors in the brain or spinal cord
  • Patients with other serious active diseases besides neuroblastoma
  • Patients with conditions that affect their ability to absorb medications
  • Patients who have previously been treated with aurora kinase inhibitors
  • Patients with known allergies to the study treatment
  • Patients with symptomatic HIV infection or active hepatitis A, B, or C

Study Objectives and Endpoints

The main objectives of this study are:[1]

  • To determine the recommended dose of LY3295668 Erbumine for future Phase 2 studies
  • To evaluate how well LY3295668 Erbumine works against neuroblastoma tumors

The study will measure several important outcomes (called “endpoints”) including:[1]

  • Dose-limiting toxicity: This refers to side effects that are severe enough to prevent increasing the dose of the drug
  • Safety measures: This includes monitoring for side effects, serious adverse events, and changes in laboratory tests
  • Overall response rate: This measures how many patients’ tumors shrink or disappear with treatment
  • Overall survival: This tracks how long patients live after starting the treatment

Drug Administration

LY3295668 Erbumine is given as a capsule that patients take by mouth. The exact dosing schedule will be determined during the study.[1]

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks to participating in this study:[1]

Potential Benefits:

  • Access to a new treatment that may be effective against neuroblastoma
  • Close monitoring by healthcare professionals
  • Contributing to the advancement of cancer research

Potential Risks:

  • Unknown side effects, as this is an early-phase study
  • The treatment may not be effective for every patient
  • Time commitment for study visits and procedures

It’s important to note that this is a Phase 1 study, which means that researchers are still learning about how this drug works in humans. Patients considering participating in this trial should discuss the potential risks and benefits thoroughly with their healthcare team.

Aspect Details
Study Type Phase 1 clinical trial
Drug Name LY3295668 Erbumine
Drug Class Aurora Kinase A inhibitor
Target Condition Relapsed/refractory neuroblastoma
Administration Oral capsules
Main Objectives Determine recommended Phase 2 dose, evaluate safety and tolerability
Key Outcomes Dose-limiting toxicity, safety, overall response rate, overall survival
Eligibility Patients with active relapsed/refractory neuroblastoma, able to swallow capsules
Exclusions Prior transplants, untreated brain/spinal cord tumors, prior aurora kinase inhibitor exposure

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to determine the recommended Phase 2 dose of LY3295668 Erbumine, both alone and in combination with other treatments, for patients with relapsed or refractory neuroblastoma. The study will also evaluate the drug's safety, tolerability, and potential effectiveness against neuroblastoma tumors.
  • Who is eligible to participate in this trial? Participants must have relapsed or refractory neuroblastoma with active disease in at least one site (bone, bone marrow, or soft tissue). They must be able to swallow capsules and provide an archival tissue sample. Patients who have had certain transplants, untreated brain or spinal cord tumors, or prior exposure to aurora kinase inhibitors are not eligible.
  • What is LY3295668 Erbumine? LY3295668 Erbumine is an investigational drug that acts as an Aurora Kinase A inhibitor. It is being studied as a potential treatment for relapsed or refractory neuroblastoma, a type of cancer that typically affects children.
  • How is the drug administered in this trial? The drug is administered orally in capsule form. Participants must be able to swallow capsules to take part in the study.
  • What are the main outcomes being measured in this trial? The main outcomes being measured include dose-limiting toxicity, safety (including treatment-emergent adverse events and serious adverse events), overall response rate, and overall survival. The study will also collect plasma samples for biomarker research.

Ongoing Clinical Trials on (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

  • Study of LY3295668 Erbumine for Patients with Relapsed or Refractory Neuroblastoma

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Neuroblastoma: A type of cancer that develops from immature nerve cells, typically affecting children. It usually begins in the adrenal glands but can also develop in other areas with nerve tissue.
  • Aurora Kinase A inhibitor: A type of drug that blocks the action of Aurora Kinase A, an enzyme involved in cell division. Inhibiting this enzyme may help slow or stop the growth of cancer cells.
  • Relapsed/Refractory: Relapsed means the cancer has returned after a period of improvement, while refractory means the cancer has not responded to treatment or has continued to grow despite treatment.
  • Phase 1 study: The first stage of clinical testing in humans, primarily focused on evaluating the safety, side effects, and best dose of a new treatment.
  • Dose-limiting toxicity: Side effects of a treatment that are severe enough to prevent an increase in dosage or require a reduction in dosage.
  • Biomarkers: Measurable indicators in the body that can provide information about a disease or the effects of a treatment.
  • Overall response rate: The proportion of patients whose cancer shrinks or disappears after treatment.
  • Overall survival: The length of time from the start of treatment that patients are still alive.

References

  1. http://clinicaltrials.eu/trial/study-of-ly3295668-erbumine-for-patients-with-relapsed-or-refractory-neuroblastoma/