Trial Title:
A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
NCT ID:
NCT06413706
Condition:
Glioma
Conditions: Official terms:
Glioma
Temozolomide
Conditions: Keywords:
Brain tumor
Central nervous system (CNS) tumor
Spinal cord tumor
Cyclin-dependent kinase (CDK) 4/6 inhibitor
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Abemaciclib
Description:
Administered orally
Arm group label:
Abemaciclib + Temozolomide - Arm A
Other name:
LY2835219
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
Administered orally or IV
Arm group label:
Abemaciclib + Temozolomide - Arm A
Arm group label:
Temozolomide - Arm B
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
- IDH-mutant astrocytoma with homozygous CDKN2A/B deletion
- Contraceptive use should be consistent with local regulations for participants in
clinical studies.
- Radiotherapy initiated within 6 weeks (+1 week) of diagnosis and administered over 6
weeks (±1 week). Participants <3 years of age, considered not suitable for
radiotherapy may be eligible.
- Minimum of 4 weeks between completion of radiation and Cycle 1 Day 1 (C1D1).
- Maximum of 8 weeks between completion of radiation and C1D1. Exceptional
circumstances can be discussed with the medical monitor.
- Acute effects of prior therapies must be Grade ≤1 unless deemed clinically
insignificant by the investigator.
- Adequate hematologic and organ function ≤7 days prior to C1D1
- Life expectancy of ≥8 weeks and deemed likely to complete at least 1 cycle of
treatment.
- A performance score of ≥60 using:
1. Lansky scale for participants <16 years
2. Karnofsky scale for participants ≥16 years
- Able to swallow and/or have a gastric/nasogastric tube.
- Any current systemic steroid use dose must be stable or decreasing at least 7 days
prior to C1D1.
- Able and willing to adhere to study procedures, including frequent blood draws and
MRI.
- At least 28 days since any major surgery, laparoscopic procedure, or a significant
traumatic injury.
- Has a body surface area (BSA) of ≥0.2 m2.
Exclusion Criteria:
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.
Gender:
All
Minimum age:
0 Years
Maximum age:
20 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Phoenix Childrens Hospital (PCH)
Address:
City:
Phoenix
Zip:
85016
Country:
United States
Investigator:
Last name:
Lindsey M Hoffman
Email:
Principal Investigator
Facility:
Name:
Lucile Packard Children's Hospital
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Investigator:
Last name:
Sonia Partap
Email:
Principal Investigator
Facility:
Name:
Nicklaus Children's Hospital
Address:
City:
Miami
Zip:
33155
Country:
United States
Contact:
Phone:
786-624-4908
Investigator:
Last name:
Ziad Khatib
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins Hospital
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Investigator:
Last name:
Kenneth Cohen
Email:
Principal Investigator
Facility:
Name:
Spectrum Health
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Investigator:
Last name:
David Hoogstra
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester, Minnesota
Address:
City:
Rochester
Zip:
55905
Country:
United States
Investigator:
Last name:
Jonathan Schwartz
Email:
Principal Investigator
Facility:
Name:
Cincinnati Childrens Hospital Medical Center
Address:
City:
Cincinnati
Zip:
45229
Country:
United States
Investigator:
Last name:
Trent Hummel
Email:
Principal Investigator
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Investigator:
Last name:
Matthew Miller
Email:
Principal Investigator
Facility:
Name:
Children's Health
Address:
City:
Dallas
Zip:
75235
Country:
United States
Investigator:
Last name:
Ashley Bui
Email:
Principal Investigator
Facility:
Name:
Cliniques universitaires Saint-Luc
Address:
City:
Brussels
Zip:
1200
Country:
Belgium
Investigator:
Last name:
An Van Damme
Email:
Principal Investigator
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Investigator:
Last name:
Sandra Jacobs
Email:
Principal Investigator
Facility:
Name:
Copenhagen University Hospital
Address:
City:
Copenhagen
Zip:
DK-2100
Country:
Denmark
Investigator:
Last name:
Karsten Nysom
Email:
Principal Investigator
Facility:
Name:
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Address:
City:
Marseille
Zip:
13385
Country:
France
Investigator:
Last name:
Nicolas Andre
Email:
Principal Investigator
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69373 CEDEX 08
Country:
France
Investigator:
Last name:
Pierre Leblond
Email:
Principal Investigator
Facility:
Name:
Institut Gustave Roussy (Igr)
Address:
City:
Villejuif
Zip:
94800
Country:
France
Investigator:
Last name:
Samuel Abbou
Email:
Principal Investigator
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75248
Country:
France
Investigator:
Last name:
Isabelle AERTS
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon
Address:
City:
Napoli
Zip:
80129
Country:
Italy
Investigator:
Last name:
lucia quaglietta
Email:
Principal Investigator
Facility:
Name:
IRCCS Istituto Giannina Gaslini
Address:
City:
Genova
Zip:
16147
Country:
Italy
Investigator:
Last name:
Claudia Milanaccio
Email:
Principal Investigator
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milan
Zip:
20133
Country:
Italy
Investigator:
Last name:
Veronica Biassoni
Email:
Principal Investigator
Facility:
Name:
Ospedale Pediatrico Bambino Gesù
Address:
City:
Rome
Zip:
00165
Country:
Italy
Investigator:
Last name:
Angela Mastronuzzi
Email:
Principal Investigator
Facility:
Name:
Osaka City General Hospital
Address:
City:
Osaka
Zip:
534-0021
Country:
Japan
Contact:
Phone:
81-6-6929-1221
Investigator:
Last name:
Keiko OKADA
Email:
Principal Investigator
Facility:
Name:
National Center for Child Health and Development
Address:
City:
Tokyo
Zip:
157-8535
Country:
Japan
Contact:
Phone:
+81-3-3416-0181
Investigator:
Last name:
Keita Terashima
Email:
Principal Investigator
Facility:
Name:
Institutul Oncologic
Address:
City:
Bucharest
Zip:
022328
Country:
Romania
Investigator:
Last name:
Monica Dragomir
Email:
Principal Investigator
Facility:
Name:
Institutul Oncologic
Address:
City:
Cluj
Zip:
400015
Country:
Romania
Investigator:
Last name:
Rodica Cosnarovici
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Investigator:
Last name:
Anna Llort Sales
Email:
Principal Investigator
Facility:
Name:
Hospital Sant Joan de Déu Barcelona
Address:
City:
Esplugues de Llobregat
Zip:
08950
Country:
Spain
Investigator:
Last name:
Miriam Pavon Mengual
Email:
Principal Investigator
Facility:
Name:
Hospital Infantil Universitario Niño Jesús
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Investigator:
Last name:
Alvaro Lassaletta Atienza
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Investigator:
Last name:
Diego Plaza Lopez de Sabando
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Virgen Del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Investigator:
Last name:
PALMA SOLANO - PAEZ
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari i Politecnic La Fe
Address:
City:
València
Zip:
46026
Country:
Spain
Investigator:
Last name:
Antonio Juan Ribelles
Email:
Principal Investigator
Start date:
October 28, 2024
Completion date:
February 2028
Lead sponsor:
Agency:
Eli Lilly and Company
Agency class:
Industry
Source:
Eli Lilly and Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06413706
