A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy

NCT06413706 | Active Not Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: 18646I3Y-MC-JPEH2022-502269-13-00U1111-1289-0405
• Study Type: interventional
• Target: 45
• Locations: 10 countries
• Sites: 37

Brief Summary

The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.

Conditions

Glioma

Keywords

Brain tumor; Central nervous system (CNS) tumor; Spinal cord tumor; Cyclin-dependent kinase (CDK) 4/6 inhibitor

Outcome Measures

Primary Outcomes (1)

• Event Free Survival as Determined by Blinded Independent Review Committee

  Event free survival as determined by blinded independent review committee.

  Baseline up to approximately 11 months

Secondary Outcomes (7)

• Event Free Survival as Determined by Investigator Assessment

  Baseline up to approximately 11 months

• Overall Survival (OS)

  Baseline to date of death due to any cause (up to approximately 18 months)

• Overall Response Rate (ORR)

  Baseline up to approximately 3 months

• Disease Control Rate (DCR)

  Baseline through to disease progression (up to approximately 3 months )

• Duration of Response (DoR)

  Date of Complete Response (CR) or Partial Response (PR) or Minor Response (MR) to date of disease progression or death (up to approximately 3 months )

Study Arms (2)

Abemaciclib + Temozolomide - Arm A

EXPERIMENTAL

Participants will receive abemaciclib administered orally in addition to temozolomide administered orally or intravenously (IV).

Drug: Abemaciclib; Drug: Temozolomide

Temozolomide - Arm B

ACTIVE COMPARATOR

Participants will receive temozolomide administered orally or IV.

Drug: Temozolomide

Interventions

Abemaciclib DRUG

Administered orally

Also known as: LY2835219

Abemaciclib + Temozolomide - Arm A

Temozolomide DRUG

Administered orally or IV

Abemaciclib + Temozolomide - Arm A; Temozolomide - Arm B

Eligibility Criteria

• Age: 0 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Biopsy proven high-grade glioma (HGG) as defined by 2016 World Health Organization (WHO) Classification Criteria, Grade 3-4 including:
• Anaplastic astrocytoma
• Anaplastic ganglioglioma
• Anaplastic oligodendroglioma.
• Anaplastic pleomorphic xanthoastrocytoma,
• Glioblastoma
• OR as defined by the 2021 WHO Classification Criteria as molecularly characterized:
• Non-pontine diffuse midline glioma, H3 K27-altered,
• Diffuse hemispheric glioma, H3 G34-mutant
• Diffuse pediatric HGG, H3/IDH-wildtype
• Infant-type hemispheric glioma
• High-grade astrocytoma with piloid features
• High-grade pleomorphic xanthoastrocytoma
• IDH-mutant diffuse glioma with homozygous cyclin- dependent kinase inhibitor 2A/B (CDKN2A/B) deletion,
• IDH-mutant and 1p/19q co-deleted oligodendroglioma

You may not qualify if:

• Participants are excluded if any of the following apply:
• Diffuse Intrinsic Pontine Glioma (DIPG) or diffuse midline glioma located in the pons.
• Recurrent or refractory HGG including any recurrence/progression during/after radiotherapy.
• Secondary HGG, defined as a previously treated low-grade glioma that now meets high- grade criteria, or that resulted from a previously treated malignancy.
• Have known pathogenic somatic mutations appropriate for an anaplastic lymphoma kinase (ALK), B-rapidly accelerated fibrosarcoma (BRAF), or neurotrophic tyrosine receptor kinase (NTRK ) inhibitor, in regions where these therapies are available and deemed appropriate by the investigator.
• Prior HGG treatment (including bevacizumab), except for surgery and radiotherapy (with or without concomitant temozolomide).
• Current enrollment in another trial deemed incompatible with this study.
• Treatment with an investigational product within the last 30 days or 5 half-lives (whichever is longer).
• Prior malignancy within the previous 3 years that, per the investigator and the medical monitor, may affect interpretation of study results.
• A preexisting medical condition(s) that, per the investigator, would preclude study participation.
• Any serious, active, systemic infection requiring IV antibiotic, antifungal, or antiviral therapy, including acute hepatitis B or C, or Human Immunodeficiency Virus at C1D1.
• Intolerability or hypersensitivity such as urticaria, anaphylaxis, toxic necrolysis, and/or Stevens-Johnson syndrome to temozolomide, and/or abemaciclib, their excipients, or dacarbazine.
• Received a live virus vaccine within 28 days of C1D1.
• Pregnant, breastfeeding, or intend to become pregnant during the study.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (37)

Children's Hospital of Orange County - Orange

Orange, California, 92868, United States

Location

Lucile Packard Children's Hospital (LPCH) - Stanford University

Palo Alto, California, 94304, United States

Location

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

The Johns Hopkins Hospital (JHH) - Johns Hopkins Childrens Center

Baltimore, Maryland, 21287, United States

Location

University of Michigan Health System (UMHS) - C.S. Mott Children's Hospital - Hematology Oncology Clinic

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

UT Southwestern Medical Center Dallas/Childrens Medical Center

Dallas, Texas, 75235, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Queensland Government- Lady Cilento Children's Hospital

Brisbane, 4101, Australia

Location

Perth Children's Hospital

Nedlands, 6009, Australia

Location

The Children's Hospital at Westmead

Westmead, 2145, Australia

Location

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

Location

Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, 1200, Belgium

Location

Copenhagen University Hospital-Rigshospitalet University Hospital

Copenhagen, 2100, Denmark

Location

Centre Hospitalier Universitaire de Bordeaux Groupe Hospitalier Pellegrin Hopital des Enfants

Bordeaux, 33076, France

Location

Centre de Lutte Contre le Cancer (CLCC) - Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Hopital La Timone

Marseille, 13885, France

Location

Institut Curie

Paris, 75005, France

Location

Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

Villejuif, 94805, France

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Azienda Ospedaliera Di Rilievo Nazionale Santobono Pausilipon

Naples, 80129, Italy

Location

IRCCS Ospedale Pediatrico Bambino Gesu

Rome, 00165, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Nagoya University Hospital

Nagoya, 466-8560, Japan

Location

Osaka City General Hospital

Osaka, 534-0021, Japan

Location

National Center for Child Health and Development (NCCHD)

Setagaya-Ku Tokyo, 157-8535, Japan

Location

Princess Maxima Center for Voor Kinderoncologie B.V

Utrecht, 3584 CS, Netherlands

Location

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, 400015, Romania

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Clinico San Carlos

Esplugues de Llobregat, 08950, Spain

Location

Hospital Infantil Universitario Nino Jesus (HIUNJS)

Madrid, 28009, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms; Neoplasms; Spinal Cord Neoplasms

Interventions

abemaciclib; Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: October 25, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

NL (1); IT (4); AU (3); FR (6); ES (6); BE (3); RO (1); DK (1); JP (3); US (9)