Phase 2  | 



CDK4 & 6 Inhibitor

A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Irinotecan and Temozolomide in Participants With Relapsed or Refractory Ewing's Sarcoma*

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Key Inclusion Criteria
  • Ages 1 to 39
  • Ewing's sarcoma or Ewing's sarcoma-like tumor
    • 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
    • Participants must have one measurable or evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Lansky score ≥50 for participants <16 years of age, and Karnofsky score ≥50 for participants ≥16 years of age 
  • 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 ≤14 days prior to day 1 of cycle 1
    • Platelets ≥75 x 109/L, hemoglobin ≥8 g/dL, and absolute neutrophil count ≥1.0 x 109/L
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN); total bilirubin ≤1.5 × ULN
    • Creatinine clearance or calculated glomerular filtration rate (GFR) ≥60 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 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 willing to follow study procedures and make themselves available for the duration of the study
Key Exclusion Criteria
  • Severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that, in the judgment of the investigator, could cause unacceptable safety risks or compromise compliance with the protocol
  • Active fungal, bacterial, and/or known severe viral infection, including but not limited to HIV or viral hepatitis A, B, or C
  • Prior allogeneic bone marrow or solid organ transplant
  • 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
  • Pregnant or breastfeeding
  • Prior treatment with a CDK4 & 6 inhibitor
  • Progression during prior treatment with irinotecan and/or temozolomide
  • Known intolerability or hypersensitivity to any of the study treatments or dacarbazine
  • Diagnosed and/or treated for an additional malignancy within 3 years prior to enrollment
This clinical trial is being conducted globally.
Abemaciclib is administered PO.
Irinotecan is administered intravenously.
Temozolomide is administered PO.
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The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.