Intervention / Treatment
- Drug: Abemaciclib
- Drug: Irinotecan
- Drug: Temozolomide
Inclusion Criteria
- Diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of Ewing’s sarcomacancer arising from bones and/or soft tissue or Ewing’s sarcoma-like tumor by institutional pathologista doctor who specialises in the study and diagnosis of disease through the examination and testing of body tissue. The original pathological report is required. Repeat biopsyremoval of a section of tissue to analyse for cancer cells at progression is not required
- Refractory disease or confirmed radiological progression or recurrenceto occur or happen again 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 cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs or investigational agents ≥7 days after the last dosethe amount of medication taken and must have recovered from the acutenew, recent, comes with an urgent or significant sense, is sudden, sharp 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)
- Plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding ≥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