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

NCT ID: NCT04238819

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2025-08-19

Brief 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.

Conditions

Relapsed Solid Tumor; Refractory Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A Cohort A1

Participants received:

• Abemaciclib: 70 mg/m², administered orally twice daily (BID).
• Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
• Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.

Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

Group Type: EXPERIMENTAL

Abemaciclib

Intervention Type: DRUG

Administered orally

Irinotecan

Intervention Type: DRUG

Administered IV

Temozolomide

Intervention Type: DRUG

Administered orally

Part A Cohort A-1

Participants received:

• Abemaciclib: 55 mg/m², administered orally BID.
• Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
• Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.

Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

Group Type: EXPERIMENTAL

Abemaciclib

Intervention Type: DRUG

Administered orally

Irinotecan

Intervention Type: DRUG

Administered IV

Temozolomide

Intervention Type: DRUG

Administered orally

Part B Cohort B1

Participants received:

• Abemaciclib: 70 mg/m², administered orally BID.
• Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.

Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

Group Type: EXPERIMENTAL

Abemaciclib

Intervention Type: DRUG

Administered orally

Temozolomide

Intervention Type: DRUG

Administered orally

Part B Cohort B2

Participants received:

• Abemaciclib: 90 mg/m², administered orally BID.
• Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.

Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

Group Type: EXPERIMENTAL

Abemaciclib

Intervention Type: DRUG

Administered orally

Temozolomide

Intervention Type: DRUG

Administered orally

Part B Cohort B3

Participants received:

• Abemaciclib: 115 mg/m², administered orally BID.
• Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.

Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

Group Type: EXPERIMENTAL

Abemaciclib

Intervention Type: DRUG

Administered orally

Temozolomide

Intervention Type: DRUG

Administered orally

Part B Cohort B5

Participants received:

• Abemaciclib: 115 mg/m², administered orally BID.
• Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.

Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

Group Type: EXPERIMENTAL

Abemaciclib

Intervention Type: DRUG

Administered orally

Temozolomide

Intervention Type: DRUG

Administered orally

Part C Cohort C1

Participants received:

• Abemaciclib: 55 mg/m², administered orally BID.
• Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
• Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
• Dinutuximab: 17.5mg/m²/day, administered IV on Days 2-5 of each cycle.
• Granulocyte-macrophage colony-stimulating factor (GM-CSF): 250 μg/m²/day, administered subcutaneously (SC) on Days 6-12 of each cycle.

Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

Group Type: EXPERIMENTAL

Abemaciclib

Intervention Type: DRUG

Administered orally

Irinotecan

Intervention Type: DRUG

Administered IV

Temozolomide

Intervention Type: DRUG

Administered orally

Dinutuximab

Intervention Type: DRUG

Administered IV

GM-CSF

Intervention Type: DRUG

Administered SC

Interventions

Abemaciclib

Administered orally

Intervention Type: DRUG

Irinotecan

Administered IV

Intervention Type: DRUG

Temozolomide

Administered orally

Intervention Type: DRUG

Dinutuximab

Administered IV

Intervention Type: DRUG

GM-CSF

Administered SC

Intervention Type: DRUG

Other Intervention Names

LY2835219

Eligibility Criteria

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

• 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.

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.
• 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.

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

United States; Australia; Belgium; France; Germany; Italy; Japan; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lillytrialguide.com/en-US/trial/7ojiQLuIsQzitz0DkvlAbe

A Study of Abemaciclib (LY2835219) in Combination With Temozolomide and Irinotecan and Abemaciclib in Combination With Temozolomide in Children and Young Adult Participants With Solid Tumors

Other Identifiers

I3Y-MC-JPCS

Identifier Type: OTHER

Identifier Source: secondary_id

2019-002931-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-506778-11-00

Identifier Type: OTHER

Identifier Source: secondary_id

16950

Identifier Type: -

Identifier Source: org_study_id