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

Completed · Phase 1/Phase 2

Conditions studied: Relapsed Solid Tumor, Refractory Solid Tumor

In brief

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.

Key facts

Study ID

NCT04238819

Run by

Eli Lilly and Company

People needed

47

Starts

2020-11-09

Expected to finish

2025-08-19

Last updated by the study team

2026-03-02

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Participants must have measurable or evaluable disease by RECIST v1.1 or RANO.
• A Lansky score ≥50 for participants <16 years of age or Karnofsky score ≥50 for participants ≥16 years of age.
• Participants must have discontinued all previous treatments for cancer or investigational agents and must have 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 drug.
• 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.

You may not qualify if…

• 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.
• Part C only: Received prior systemic therapy for relapsed/refractory neuroblastoma.
• Part C only, have 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.
• Has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.

Where it is running

• 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
• Children's Hospital of Philadelphia (CHOP) — Philadelphia, Pennsylvania, United States
• Lifespan Cancer Institute — Providence, Rhode Island, United States
• Perth Children's Hospital — Perth, Western Australia, Australia
• UZ Gent — Ghent, Oost-Vlaanderen, Belgium
• Centre Leon Berard — Lyon, Rhône, France
• Gustave Roussy — Villejuif, Val-de-Marne, France
• Institut Curie — Paris, France
• Universitaetsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg, Germany
• Universitaetsklinikum Essen — Essen, North Rhine-Westphalia, Germany
• Charité Campus Virchow-Klinikum — Berlin, Germany
• Fondazione Policlinico Universitario Agostino Gemelli — Rome, Lazio, Italy
• National Cancer Center Hospital — Chuo Ku, Tokyo, Japan
• Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [Barcelona], Spain
• Hospital Infantil Universitario Niño Jesús — Madrid, Madrid, Comunidad de, Spain
• Hospital Universitari i Politecnic La Fe — Valencia, Spain

Full record on ClinicalTrials.gov

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