CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Abemaciclib: Orally
Irinotecan: IV
Temozolomide: Orally
Study 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.
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis — From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months)
PFS was defined as the time from randomization until the first occurrence of documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause in absence of progressive disease, whichever came first. Progressive disease (PD) was defined as at least 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using Bayesian analysis and are reported as posterior mean along with its 80% credible interval. - PFS Assessed by BIRC by Frequentist Analysis — From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months)
PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using frequentist analysis.
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | |
| The Regents of the University of California - Los Angeles (UCLA Pediatrics) | Los Angeles | California | |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | |
| Washington University | St Louis | Missouri | |
| Lifespan Cancer Institute | Providence | Rhode Island | |
| The Children's Hospital at Westmead | Westmead | New South Wales | |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | |
| Royal Children's Hospital | Melbourne | Victoria | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Bordeaux | Aquitaine | |
| Centre Leon Berard | Lyon | Auvergne-Rhône-Alpes | |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | |
| Universitätsklinikum Essen | Essen | North Rhine-Westphalia | |
| Charité Campus Virchow-Klinikum | Berlin | Germany | |
| Fondazione Policlinico Universitario Agostino Gemelli | Rome | Lazio | |
| IRCCS Istituto Ortopedico Rizzoli | Bologna | Italy | |
| Hyogo Prefectural Kobe Children's Hospital | Kobe | Hyōgo | |
| National Cancer Center Hospital | Chuo-ku | Tokyo | |
| Kyushu University Hospital | Fukuoka | Japan | |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | |
| Hospital Sant Joan de Déu | Esplugues de Llobregat | Barcelona [Barcelona] | |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalunya [Cataluña] | |
| Hospital Infantil Universitario Niño Jesús | Madrid | Madrid, Comunidad de | |
| Hospital Universitario La Paz | Madrid | Madrid, Comunidad de | |
| Hospital General Universitario Gregorio Marañon | Madrid | Spain | |
| Hospital General Universitario Gregorio Marañon | Madrid | Spain | |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | |
| Hospital Universitario La Paz | Madrid | Spain | |
| Hospital Universitario Virgen Del Rocio | Seville | Spain | |
| Hospital Universitari i Politecnic La Fe | Valencia | Spain |
On this site
📄 Verzenio (abemaciclib) drug profile →More Eli Lilly and Company trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05440786 on ClinicalTrials.gov ↗ ← All trials in Japan