CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma (NCT05440786) | Clinical Trial Compass
Active — Not RecruitingPhase 2
CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
United States, Australia, France46 participantsStarted 2022-09-20
Plain-language summary
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.
Who can participate
Age range
1 Year – 39 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 te…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis
Timeframe: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months)
2
PFS Assessed by BIRC by Frequentist Analysis
Timeframe: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months)