CDK4/6 Inhibitor
Abemaciclib
Phase
2
Enrolling
A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Irinotecan and Temozolomide in Participants With Relapsed or Refractory Ewing's Sarcoma*
Related Resources:
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 cyclin-dependent kinase 4 and 6 (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.
