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Study of Abemaciclib, Irinotecan, and Temozolomide for Patients with Relapsed or Refractory Ewing's Sarcoma

Verified siteRegistered drugNo 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 Ewing's Sarcoma, which can occur in bones or the soft tissue around bones. The study is investigating the effects of a treatment that combines three medications: Abemaciclib, Irinotecan, and Temozolomide. Abemaciclib, also known by its code name LY2835219, is a medication that comes in the form of tablets or granules and is taken orally. Irinotecan is administered intravenously, meaning it is given through a vein, and Temozolomide is taken orally as well.

The purpose of this study is to determine if adding Abemaciclib to the chemotherapy drugs Irinotecan and Temozolomide can provide benefits for patients whose Ewing's Sarcoma has returned or did not respond to previous treatments. Participants in the study will receive these medications over a period of time, and their health will be monitored to see how the cancer responds to the treatment. The study aims to understand if this combination of medications can help control the disease better than the standard treatments alone.

Throughout the study, participants will be closely observed by medical professionals to ensure their safety and to track the effectiveness of the treatment. The study will help gather important information about the potential benefits of this new treatment approach for Ewing's Sarcoma, which could lead to improved care for patients in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant must have a confirmed diagnosis of Ewing's sarcoma or a similar tumor. A negative pregnancy test is required for female participants of childbearing potential within 7 days before starting the first cycle.

    The participant must have experienced disease progression or recurrence after previous treatments and have at least one measurable lesion. Participants should be between 1 and 39 years old, weigh at least 10 kg, and have adequate performance status and organ function.

    Participants must be able to swallow medication or have a gastric/nasogastric tube. In the European Union, swallowing intact capsules is necessary. All previous cancer treatments must be discontinued, and any acute effects should be resolved to a mild level before enrollment.

  2. Step 2

    Treatment cycle

    The treatment involves a combination of medications: abemaciclib, irinotecan, and temozolomide. Abemaciclib is administered orally in the form of tablets.

    Irinotecan is given intravenously, which means it is delivered directly into a vein. Temozolomide is taken orally as well.

    The specific dosage, frequency, and duration of each medication will be determined by the study protocol and the healthcare team overseeing the trial.

  3. Step 3

    Monitoring and evaluation

    Throughout the study, the participant's health and response to treatment will be closely monitored. This includes regular assessments to evaluate the progression of the disease.

    The primary goal is to measure progression-free survival, which refers to the length of time during and after treatment that the participant lives with the disease without it getting worse.

    Assessments will be conducted using standardized criteria to ensure accurate and consistent evaluation of the participant's condition.

  4. Step 4

    Completion of the study

    The study is expected to conclude by April 1, 2026. Participants will continue to receive treatment and monitoring until the study's end date or until specific criteria for discontinuation are met.

    Upon completion, the data collected will be analyzed to determine the effectiveness of the treatment combination in managing Ewing's sarcoma.

Who can join the trial?

10 criteria

  • You must have a diagnosis of Ewing's sarcoma or a tumor similar to Ewing's sarcoma.
  • If you are a female who can have children, you must have a negative pregnancy test within 7 days before starting the study.
  • Your disease must have shown confirmed growth or not responded to previous treatments, or it has come back after treatment. You must have at least one tumor that can be measured or evaluated.
  • You must be between 1 and less than 40 years old.
  • You must weigh at least 10 kilograms (about 22 pounds).
  • You must have a good level of daily functioning based on your age. If you are under 16, you need a Lansky score of 50 or more. If you are 16 or older, you need a Karnofsky score of 50 or more. These scores measure how well you can carry out daily activities.
  • Your blood and organs must be working well within 14 days before starting the study.
  • You must be able to swallow or have a tube that goes to your stomach or nose for taking medicine.
  • If you are in the European Union, you must be able to swallow whole capsules.
  • You must have stopped all previous cancer treatments or experimental drugs and recovered from any immediate side effects to a mild level before joining the study.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer other than Ewing's Sarcoma cannot participate. Ewing's Sarcoma is a type of cancer that usually starts in the bones or soft tissue around the bones.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have had certain treatments recently that might affect the study results cannot participate.
  • Patients who are unable to provide consent or do not have a legal guardian to provide consent cannot participate.
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Investigated drugs

  • Abemaciclib

    is a medication used in this trial to see if it can help treat Ewing's sarcoma, a type of cancer, when combined with other chemotherapy drugs. It works by blocking certain proteins that cancer cells need to grow.

  • Irinotecan

    is a chemotherapy drug used in this study to help treat Ewing's sarcoma. It works by interfering with the DNA of cancer cells, which can stop them from growing and dividing.

  • Temozolomide

    is another chemotherapy medication used in this trial. It helps treat Ewing's sarcoma by damaging the DNA of cancer cells, which can lead to their death and help stop the cancer from spreading.

What is already known about the treatment

  • Abemaciclib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating Ewing's Sarcoma, particularly in cases where the cancer has returned or not responded to previous treatments. Abemaciclib is a targeted therapy known as a CDK4/6 inhibitor, which works by blocking proteins that promote cell division, thereby slowing down the growth of cancer cells. It is classified as an antineoplastic agent and is being evaluated for its potential to enhance the effects of chemotherapy when used in combination with other drugs.

  • Irinotecan

    This medication is typically administered intravenously and is used in the treatment of various cancers, including Ewing's Sarcoma, as part of combination chemotherapy. Irinotecan works by inhibiting an enzyme called topoisomerase I, which is essential for DNA replication, leading to the death of rapidly dividing cancer cells. It is classified as a topoisomerase inhibitor and is being studied for its effectiveness in combination with other drugs to improve outcomes in relapsed or refractory cases.

  • Temozolomide

    This medication is taken orally and is used in the treatment of certain types of brain tumors and other cancers, including Ewing's Sarcoma. Temozolomide is an alkylating agent that works by damaging the DNA of cancer cells, preventing them from dividing and growing. It is being investigated in combination with other therapies to determine its efficacy in treating cancers that have not responded to standard treatments.

Investigated diseases

Ewing's Sarcoma – Ewing's Sarcoma is a rare type of cancer that typically occurs in bones or the soft tissue around the bones. It most commonly affects children and young adults. The disease often begins in the long bones of the arms and legs, pelvis, or chest. It can cause pain and swelling in the affected area. As it progresses, it may lead to fatigue, fever, and weight loss. The cancer can also spread to other parts of the body, such as the lungs or other bones.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506772-28-00Protocol codeJ1S-MC-JP04Estimated enrolment41 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

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