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New hope for kids with resistant cancers? drug combo shows promise in early trial

NCT ID NCT04238819

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the safety and effectiveness of the drug abemaciclib combined with other cancer medicines in 47 children and young adults whose solid tumors (including neuroblastoma) had stopped responding to standard treatments. The goal was to find the best dose and see if the combination could shrink tumors. The study lasted up to 2 years per participant and focused on managing the disease rather than providing a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

47 people

The number who actually took part.

Started

Nov 2020

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

brain cancer diffuse intrinsic pontine glioma ependymoma Ewing sarcoma glioblastoma glioma medulloblastoma neuroblastoma osteosarcoma refractory malignant neoplasm rhabdoid tumor rhabdomyosarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Refractory solid tumor Relapsed solid tumor

Contacts and locations

Locations

  • Atrium Health - Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Centre Leon Berard

    Lyon, Rhône, 69373 CEDEX 08, France

  • Charité Campus Virchow-Klinikum

    Berlin, 13353, Germany

  • Children's Hospital of Philadelphia (CHOP)

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Cohen Children's Medical Center

    New Hyde Park, New York, 11040, United States

  • Fondazione Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 168, Italy

  • Gustave Roussy

    Villejuif, Val-de-Marne, 94800, France

  • Hospital Infantil Universitario Niño Jesús

    Madrid, Madrid, Comunidad de, 28009, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 8035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Institut Curie

    Paris, 75248, France

  • Kaiser Permanente Oakland

    Oakland, California, 94611, United States

  • Kaiser Permanente Roseville

    Roseville, California, 95661, United States

  • Kaiser Permanente Santa Clara

    Santa Clara, California, 95051, United States

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02906, United States

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, 104-0045, Japan

  • Perth Children's Hospital

    Perth, Western Australia, 6009, Australia

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana, 46202, United States

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

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

    Los Angeles, California, 90095-1752, United States

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Universitaetsklinikum Essen

    Essen, North Rhine-Westphalia, 45122, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

More trials for these conditions

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