CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma

Open to people ages 1-39

• 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 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

• Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
• Participants with an active fungal, bacterial, and/or known severe viral infection including, but not limited to, human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis.
• Participants who have had allogeneic bone marrow or solid organ transplant
• Surgery: Participants who have had, or are planning to have, the following invasive procedures:
  • Major surgical procedure, laparoscopic procedure, or significant traumatic injury within 28 days prior to enrollment
  • Surgical or other wounds must be adequately healed prior to enrollment
• Female participants who are pregnant or breastfeeding
• Have received any prior cyclin-dependent kinase (CDK) 4 and 6 inhibitor
• Progression during prior treatment with irinotecan and/or temozolomide
• Have a known intolerability or hypersensitivity to any of the study treatments or dacarbazine
• Diagnosed and/or treated additional malignancy within 3 years prior to enrollment