CDK4/6 Inhibitor

A Phase 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)*

NCT04238819 show modal icon
Key Inclusion Criteria

Parts A and B only:

  • ≤18 years of age
  • Body weight ≥10 kilograms and body surface area (BSA) ≥0.5 m²
  • Any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies
  • For parts B and C, participants with neuroblastoma who are eligible for part C will be excluded from part B unless approved by the investigator

Part C only:

  • <21 years of age
  • BSA ≥0.2 m²
  • First relapse/refractory neuroblastoma

All parts:

  • Measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-Oncology (RANO)
  • A Lansky score ≥50 for participants <16 years of age or Karnofsky score ≥50 for participants ≥16 years of age
  • Discontinued all previous treatments for cancer or investigational agents and recovered from the acute effects to grade ≤1 at the time of enrollment
  • Able to swallow and/or have a gastric/nasogastric tube
  • Adequate hematologic and organ function ≤2 weeks (14 days) prior to first dose of study treatment
  • Females of reproductive potential must have negative urine or serum pregnancy test at baseline (within 7 days prior to starting treatment)
  • Female participants of reproductive potential must agree to use highly effective contraceptive precautions during the trial. For abemaciclib, females should use contraception for at least 3 weeks following the last abemaciclib. For other study drugs, highly effective contraceptive precautions (and avoiding sperm donation) must be used according to their label
  • Life expectancy of at least 8 weeks and able to complete at least 1 cycle of treatment
  • Caregivers and participants willing to make themselves available for the duration of the trial
Key Exclusion Criteria
  • Prior allogenic bone marrow or solid organ transplant
  • Prior live vaccination
  • Intolerability or hypersensitivity to any of the study treatments or its components
  • Diagnosed and/or treated additional malignancy within 3 years prior to enrollment that may affect the interpretation of results, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or breast cancers
  • Pregnant or breastfeeding
  • Active systemic infections
  • Serious and/or uncontrolled preexisting medical condition(s)
  • Parts A and C only: Bowel obstruction
  • Prior treatment with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450 3A (CYP3A) or strong inhibitors of uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) if the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to starting study treatment
  • Prior treatment with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor
  • Part C only: Received prior systemic therapy for relapsed/refractory neuroblastoma
  • Part C only: Received prior anti-GD2 therapy during induction phase
  • Currently enrolled in any other clinical study involving an investigational product or non-approved use of a drug or device
  • Received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer
This clinical trial is being conducted globally.
Additional criteria not shown here may exist for individual parts of the study.
Abemaciclib is administered PO.
Irinotecan is administered intravenously (IV).
Temozolomide is administered PO or IV.
Dinutuximab is administered IV.
GM-CSF is administered subcutaneously.
For information on trial enrollment, locations, and more, call 1-800-545-5979.

or visit www.clinicaltrials.gov for more information on this trial