Fact CheckerSign in

NCT05440786Active, not recruitingPhase 2

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

A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Irinotecan and Temozolomide in Participants With Relapsed or Refractory Ewing's Sarcoma

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
46 (actual)
First submitted
28 Jun 2022
Start date
20 Sept 2022
Primary completion date
15 Jan 2025
Lead sponsor
Eli Lilly and Company
NCT number
NCT05440786
EU CT number
2023-506772-28-00
EudraCT number
2021-004734-11

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 46
  • From 20 Sept 2022 to the primary completion date, 15 Jan 2025
  • 27 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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
  • Have received any prior cyclin-dependent kinase (CDK) 4 and 6 inhibitor
  • Progression during prior treatment with irinotecan and/or temozolomide
  • Diagnosed and/or treated additional malignancy within 3 years prior to enrollment

Other illness

  • 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.
  • Have a known intolerability or hypersensitivity to any of the study treatments or dacarbazine

Other

  • Female participants who are pregnant or breastfeeding

Who the study is looking for

  • 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

Age in the registry: 1 year to 39 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Children's Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Peter MacCallum Cancer Centre
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
The Children's Hospital at Westmead
Coordinator of this site? Confirm its status
WestmeadAustraliaUnknown status
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Universitaetsklinikum Essen (AoR)
Coordinator of this site? Confirm its status
EssenGermanyCompleted
Medical Center- University of Freiburg
Coordinator of this site? Confirm its status
Freiburg im BreisgauGermanyCompleted
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainCompleted
Hospital de la Santa Creu i Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainCompleted
Sant Joan De Deu Barcelona Hospital
Coordinator of this site? Confirm its status
Esplugues De LlobregatSpainCompleted
Hospital Infantil Universitario Nino Jesus
Coordinator of this site? Confirm its status
MadridSpainCompleted
Hospital General Universitario Gregorio Marañón
Coordinator of this site? Confirm its status
MadridSpainCompleted
Hospital Universitario La Paz
Coordinator of this site? Confirm its status
MadridSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainCompleted
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainCompleted
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainCompleted
Institut Bergonie
Coordinator of this site? Confirm its status
BordeauxFranceCompleted
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceCompleted
Istituto Ortopedico Rizzoli
Coordinator of this site? Confirm its status
BolognaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyCompleted
National Cancer Center Hospital
Coordinator of this site? Confirm its status
Chuo KuJapanUnknown status
Kyushu University Hospital
Coordinator of this site? Confirm its status
FukuokaJapanUnknown status
Hyogo Prefectural Kobe Children's Hospital
Coordinator of this site? Confirm its status
KobeJapanUnknown status
Riley Hospital for Children at Indiana University Health
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
The Regents of the University of California - Los Angeles (UCLA Pediatrics)
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Phoenix Children s Hospital
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Lifespan Cancer Institute
Coordinator of this site? Confirm its status
ProvidenceUnited StatesUnknown status
Washington University
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.