The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolamide) 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Progression Free Survival (PFS)
PFS determined by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)
Time frame: Baseline to objective progression or death due to any cause (estimated up to 11 months)
Overall Survival (OS)
OS
Time frame: Baseline to date of death due to any cause (estimated up to 45 months)
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR
ORR
Time frame: Baseline to measured progressive disease (estimated up to 11 months)
Duration of Response (DoR)
DoR
Time frame: Date of first evidence of CR or PR to date of disease recurrence, objective disease progression, or death due to any cause (estimated up to 11 months)
Disease Control Rate (DCR)
DCR
Time frame: Baseline to measured progressive disease (estimated up to 11 months)
PFS
PFS determined by investigator assessment using RECIST 1.1
Time frame: Baseline to objective progression or death due to any cause (estimated up to 11 months)
Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of Abemaciclib
PK: Cmin of Abemaciclib
Time frame: Cycle 3, Day 1 (21 day cycles)
Abemaciclib Product Acceptability
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 19 more locations
Participants evaluated abemaciclib acceptability (palatability and ease of administration) using a 5-category questionnaire. Participants were asked to select one of the following to describe the acceptability of abemaciclib: Very difficult, difficult, neither easy nor difficult, easy, or very easy.
Time frame: Day 1 of Cycles 1 through 3 (21 day cycles)