In short
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.
At a glance
- 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
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.
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.
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.
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:
- 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:
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:
- 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:
- 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.
Potential Benefits and Risks
As with any experimental treatment, there are potential benefits and risks to participating in this study:
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.