Ewing's Sarcoma MedDRA version: 20.0 Level: PT Classification code 10015560 Term: Ewing's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of Ewing’s sarcoma or Ewing’s sarcoma-like tumor - Confirmed radiological progression or refractory disease or recurrence following first or later line of treatment of Ewing's sarcoma or Ewing's sarcoma-like tumor, and must have one measurable or evaluable lesion per RECIST 1.1 - Participants aged 1 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Have received any prior CDK4 and 6 inhibitor - Progression during prior treatment with irinotecan or temozolomide - Currently enrolled in a clinical study involving an investigational product, or any other type of medical research judged not to be scientifically or medically compatible with this study - A serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the safety profile of abemaciclib, irinotecan, and temozolomide combination To characterize the clinical activity of the abemaciclib, irinotecan, and temozolomide combination To characterize the PK of the abemaciclib in combination with irinotecan +temozolomide To assess the acceptability and palatability of the age-appropriate tablet and/or granule drug product, including dispersed tablets and/or granules;Primary end point(s): PFS as determined by BIRC using RECIST 1.1 ;Timepoint(s) of evaluation of this end point: When approximatively 34 PFS events out of the 45 randomized participants will have been observed by blinded independent review committee. ;Main Objective: To characterize the efficacy of abemaciclib in combination with irinotecan + temozolomide | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety (including but not limited to): TEAEs, SAEs, deaths, laboratory abnormalities, vital signs, and physical examinations OS ORR DoR DCR PFS as determined by investigator Concentrations of abemaciclib Assessment of tablet, granule, or dispersed drug product presentation, including acceptability and palatability ;Timepoint(s) of evaluation of this end point: When approximatively 34 PFS events out of the 45 randomized participants will have been observed by blinded independent review committee. At the end of the study. | — |
Countries
Australia, France, Germany, Italy, Japan, Spain, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed