CDK4/6 Inhibitor
Abemaciclib
Phase
2
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:
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.
