Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Hope for Tough-to-Treat bone cancer: new combo trial launches

NCT ID NCT05440786

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the drug abemaciclib to standard chemotherapy can help people with Ewing's sarcoma whose cancer has returned or not responded to treatment. About 46 children and young adults will take part. The goal is to see if the combination slows tumor growth better than chemotherapy alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

46 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 39 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of Ewing's sarcoma or Ewing's sarcoma-like tumor by institutional pathologist. The original pathological report is required. Repeat biopsy at progression is not required * Refractory disease or confirmed radiological progression or recurrence following first or later line of treatment of Ewing's sarcoma or Ewing's sarcoma-like tumor \-- Must have one measurable or evaluable lesion per RECIST 1.1 * Adequate performance status based on age * For participants less than (\<)16 years of age, a Lansky score greater than or equal to (≥)50, or * For participants ≥16 years of age, a Karnofsky score ≥50 * Participants must have discontinued all previous treatments for cancer or investigational agents ≥7 days after the last dose and must have recovered from the acute effects * Adequate hematologic and organ function less than or equal to (≤)14 days prior to Day 1 of Cycle 1: * Absolute neutrophil count ≥1000/microliter (µL) * Platelets ≥75,000/cubic millimeter (mm³) * Hemoglobin ≥8 grams per deciLiter (g/Dl) (≥100 grams per Liter \[g/L\]) * Total bilirubin ≤1.5 times (×) upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN * Creatinine clearance or calculated glomerular filtration rate (GFR) ≥60 milliliters per minute per square meter (Ml/min/m²) or serum creatinine based on age/gender * Female participants of childbearing potential must have a negative urine or serum pregnancy test * Body weight ≥10 kilograms (kg) * Must be able to swallow and/or have a gastric/nasogastric tube \-- Participants in the European Union must be able to swallow intact capsules * Stable or decreasing dose of steroids at least 7 days prior to enrollment * Life expectancy of at least 8 weeks and able to complete at least 1 cycle of treatment * Participants/caregivers are able and willing to make themselves available for the duration of the study and are willing to follow study procedures, including adherence to the pharmacokinetic (PK) sampling schedule Exclusion Criteria: * Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol * Participants with an active fungal, bacterial, and/or known severe viral infection including, but not limited to, human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis. * Participants who have had allogeneic bone marrow or solid organ transplant * Surgery: Participants who have had, or are planning to have, the following invasive procedures: * Major surgical procedure, laparoscopic procedure, or significant traumatic injury within 28 days prior to enrollment * Surgical or other wounds must be adequately healed prior to enrollment * Female participants who are pregnant or breastfeeding * Have received any prior cyclin-dependent kinase (CDK) 4 and 6 inhibitor * Progression during prior treatment with irinotecan and/or temozolomide * Have a known intolerability or hypersensitivity to any of the study treatments or dacarbazine * Diagnosed and/or treated additional malignancy within 3 years prior to enrollment

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Ewing's sarcoma-like tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Ewing sarcoma Ewing sarcoma/peripheral primitive neuroectodermal tumor metastatic neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasm metastasis Sarcoma, Ewing

Contacts and locations

Locations

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69373 CEDEX 08, France

  • Charité Campus Virchow-Klinikum

    Berlin, 13353, Germany

  • Fondazione Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168, Italy

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009, Spain

  • Hospital Infantil Universitario Niño Jesús

    Madrid, Madrid, Comunidad de, 28009, Spain

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario La Paz

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalunya [Cataluña], 08041, Spain

  • Hyogo Prefectural Kobe Children's Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • IRCCS Istituto Ortopedico Rizzoli

    Bologna, 40136, Italy

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, Aquitaine, 33076, France

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02906, United States

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana, 46202, United States

  • Royal Children's Hospital

    Melbourne, Victoria, 3052, Australia

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145, Australia

  • The Regents of the University of California - Los Angeles (UCLA Pediatrics)

    Los Angeles, California, 90095-1752, United States

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45122, Germany

  • Washington University

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.