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
- Diseases
- Childhood cancers, Sarcoma
- 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
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Children's Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Sant Joan De Deu Barcelona Hospital Coordinator of this site? Confirm its status | Esplugues De Llobregat | Spain | Completed |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| Istituto Ortopedico Rizzoli Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Unknown status |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Hyogo Prefectural Kobe Children's Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Riley Hospital for Children at Indiana University Health Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| The Regents of the University of California - Los Angeles (UCLA Pediatrics) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Phoenix Children s Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Lifespan Cancer Institute Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.