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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
CDK4/6 Inhibitor
Abemaciclib
Phase
2
Not Enrolling

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)*†

Related Resources:
Molecule Overview Trial Enrollment
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.
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