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A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma

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•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment. For each participant, the study is estimated to last up to 2 years.

Eligibility

Age

0 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Parts A and B only:
•* Participants must be less than or equal to (≤)18 years of age.
•* Body weight greater than or equal to (≥)10 kilograms and body surface area (BSA) ≥0.5
•* Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies.
•* For sites that are actively enrolling Parts B and C, participants with neuroblastoma who are eligible for Part C will be excluded from Part B unless approved by Lilly CRP/CRS.
•Part C only:
•* Participants must be less than (\<) 21 years of age.
•* Participants have a BSA ≥0.2 m².
•* Participants with first relapse/refractory neuroblastoma.
•All Parts
+9 more criteria

Exclusion Criteria

•Received allogenic bone marrow or solid organ transplant.
•Received 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) that would preclude participation in this study.
•Parts A and C only: Have a 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 drug.
•Received prior treatment with cyclin-dependent kinase (CDK) 4 \& 6 inhibitor.
+4 more criteria

Locations (25)

Phoenix Children's Hospital

Phoenix, Arizona, United States

The Regents of the University of California - Los Angeles (UCLA Pediatrics)

Los Angeles, California, United States

Kaiser Permanente Oakland

Oakland, California, United States

Kaiser Permanente Roseville

Roseville, California, United States

Kaiser Permanente Santa Clara

Santa Clara, California, United States

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Spectrum Health

Grand Rapids, Michigan, United States

Cohen Children's Medical Center

New Hyde Park, New York, United States

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

November 9, 2020

Primary Completion Date

March 15, 2024

Completion Date

August 19, 2025

Last Updated

March 2, 2026

Enrollment

ACTUAL participants

Conditions

Relapsed Solid TumorRefractory Solid Tumor

Interventions

Abemaciclib

DRUG

Irinotecan

DRUG

Temozolomide

DRUG

Dinutuximab

DRUG

GM-CSF

DRUG

Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors

NCT03739827

Malignant Solid TumorsOther Neoplasms Solid Tumors+3 more

View study

RECRUITINGPHASE1/PHASE2

PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors

NCT06721689

Refractory Solid TumorsRelapsed Solid Tumors+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma

Inclusion Criteria

Exclusion Criteria

Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors

PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors

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