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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

Study Purpose

The study's purpose is to see if the drug abemaciclib is safe and effective in combination with temozolomide and irinotecan (Part A) and abemaciclib in combination with temozolomide (Part B) in pediatric and young adult participants with relapsed/refractory solid tumors.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Body weight ≥10 kilograms and body surface area (BSA) ≥0.5 meters squared.
  • - Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies and, in the judgment of the investigator, are appropriate candidates for the experimental therapy combination in the study part that is currently enrolling.
  • - Participants must have at least one measurable (per Response Criteria in Solid Tumors [RECIST v1.1; [Eisenhauer et al.
2009] or Response Assessment in Neuro-Oncology (RANO) for central nervous system (CNS) tumors [Wen et al. 2010]) or evaluable lesion.
  • - Participants must have had histologic verification of malignancy at original diagnosis or relapse, except: - Participants with extra-cranial germ-cell tumors who have elevations of serum tumor markers including alpha-fetoprotein or beta- human chorionic gonadotropin (HCG).
  • - Participants with intrinsic brain stem tumors or participants with CNS-germ cell tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or beta-HCG.
  • - 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.
  • - Adequate hematologic and organ function ≤2 weeks (14 days) prior to first dose of study drug.
  • - Females of reproductive potential must have negative serum pregnancy test at baseline (within 7 days prior to starting treatment).
  • - Both female and male participants of reproductive potential must agree to use highly effective contraceptive precautions (and avoid sperm donation for males) during the trial.
For abemaciclib, females should use contraception for at least 3 weeks following the last abemaciclib dose (males have no restriction for contraceptive use following treatment with 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 (within 4 weeks prior to starting study treatment).
  • - Have a personal history of any of the following conditions within the last 12 months: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
  • - 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 or viral load.
  • - Serious and/or uncontrolled preexisting medical condition(s) that would preclude participation in this study.
  • - Have a bowel obstruction (Part A of this study only).
  • - Treated 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.
  • - 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.
  • - Tumor contains known somatic or germline retinoblastoma (RB) mutation.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04238819
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, France, Germany, Italy, Japan, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsed Solid Tumor, Refractory Solid Tumor
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Dose Escalation: Abemaciclib + Irinotecan + Temozolomide

Abemaciclib given orally, irinotecan given intravenously (IV) and temozolomide given orally.

Experimental: Dose Expansion: Abemaciclib + Irinotecan + Temozolomide

Abemaciclib given orally, irinotecan given IV and temozolomide given orally.

Experimental: Dose Escalation: Abemaciclib + Temozolomide

Abemaciclib and temozolomide given orally.

Experimental: Dose Expansion: Abemaciclib + Temozolomide

Abemaciclib and temozolomide given orally.

Interventions

Drug: - Abemaciclib

Administered orally

Drug: - Irinotecan

Administered IV

Drug: - Temozolomide

Administered orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix Childrens Hospital, Phoenix, Arizona

Status

Recruiting

Address

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

University of Minnesota Hospital, Minneapolis, Minnesota

Status

Not yet recruiting

Address

University of Minnesota Hospital

Minneapolis, Minnesota, 55455

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

International Sites

UZ-Gent, Gent, Belgium

Status

Recruiting

Address

UZ-Gent

Gent, , 9000

Centre Leon Berard, Lyon CEDEX 08, Rhône-Alpes, France

Status

Recruiting

Address

Centre Leon Berard

Lyon CEDEX 08, Rhône-Alpes, 69373

Institut Curie, Paris, France

Status

Recruiting

Address

Institut Curie

Paris, , 75248

Gustave Roussy, Villejuif Cedex, France

Status

Recruiting

Address

Gustave Roussy

Villejuif Cedex, , 94805

Berlin, Germany

Status

Recruiting

Address

Charité Universitätsmedizin Berlin Campus Buch

Berlin, , 13353

Universtitätsklinikum Essen AöR, Essen, Germany

Status

Recruiting

Address

Universtitätsklinikum Essen AöR

Essen, , 45147

Heidelberg, Germany

Status

Recruiting

Address

Hopp-Kindertumorzentrum Heidelberg (KiTZ)

Heidelberg, , 69120

Policlinico Univ. Agostino Gemelli, Roma, Italy

Status

Recruiting

Address

Policlinico Univ. Agostino Gemelli

Roma, , 00168

National Cancer Center Hospital, Chuo-ku, Tokyo, Japan

Status

Recruiting

Address

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045

Hospital Universitari Vall d'Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebron

Barcelona, , 08035

Madrid, Spain

Status

Recruiting

Address

Hospital Infantil Universitario Niño Jesús

Madrid, , 28009

Hospital Universitario La Fe de Valencia, Valencia, Spain

Status

Recruiting

Address

Hospital Universitario La Fe de Valencia

Valencia, , 46026