CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma

Running, not enrolling · Phase 2

Conditions studied: Sarcoma, Ewing, Neoplasm Metastasis

In brief

The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolomide) for Ewing's sarcoma that has come back or did not respond to treatment. This trial is part of the CAMPFIRE master protocol, which is a platform to speed development of new treatments for children and young adults with cancer. Your participation in this trial could last 11 months or longer, depending on how you and your tumor respond.

Key facts

Study ID: NCT05440786
Run by: Eli Lilly and Company
People needed: 46
Starts: 2022-09-20
Expected to finish: 2026-12-01
Last updated by the study team: 2026-04-13

Who can join

Age: 1 and older, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Phoenix Children's Hospital — Phoenix, Arizona, United States
The Regents of the University of California - Los Angeles (UCLA Pediatrics) — Los Angeles, California, United States
Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
Washington University — St Louis, Missouri, United States
Lifespan Cancer Institute — Providence, Rhode Island, United States
The Children's Hospital at Westmead — Westmead, New South Wales, Australia
Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
Royal Children's Hospital — Melbourne, Victoria, Australia
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest — Bordeaux, Aquitaine, France
Centre Leon Berard — Lyon, Auvergne-Rhône-Alpes, France
Universitaetsklinikum Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitätsklinikum Essen — Essen, North Rhine-Westphalia, Germany
Charité Campus Virchow-Klinikum — Berlin, Germany
Fondazione Policlinico Universitario Agostino Gemelli — Rome, Lazio, Italy
IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy
Hyogo Prefectural Kobe Children's Hospital — Kobe, Hyōgo, Japan
National Cancer Center Hospital — Chuo-ku, Tokyo, Japan
Kyushu University Hospital — Fukuoka, Japan
Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [Barcelona], Spain
Hospital Sant Joan de Déu — Esplugues de Llobregat, Barcelona [Barcelona], Spain
Hospital de la Santa Creu i Sant Pau — Barcelona, Catalunya [Cataluña], Spain
Hospital Infantil Universitario Niño Jesús — Madrid, Madrid, Comunidad de, Spain
Hospital Universitario La Paz — Madrid, Madrid, Comunidad de, Spain
Hospital General Universitario Gregorio Marañon — Madrid, Spain
Hospital General Universitario Gregorio Marañon — Madrid, Spain

Full record on ClinicalTrials.gov

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