Multiparametric MR-PET Imaging Predicts Pharmacokinetics and Clinical Response to GDC-0084 in Patients with Recurrent High-Grade Glioma.

Adult Aged Brain / diagnostic imaging Female Glioma / diagnosis Humans Image Processing, Computer-Assisted Magnetic Resonance Imaging / methods Male Middle Aged Molecular Targeted Therapy / methods Neoplasm Grading Oxazines / administration & dosage Positron-Emission Tomography / methods Prognosis Progression-Free Survival Protein Kinase Inhibitors / administration & dosage Pyrimidines / administration & dosage Recurrence Treatment Outcome

Journal

Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500

Informations de publication

Date de publication:
01 07 2020
Historique:
received: 23 11 2019
revised: 14 02 2020
accepted: 03 04 2020
pubmed: 10 4 2020
medline: 15 9 2021
entrez: 10 4 2020
Statut: ppublish

Résumé

GDC-0084 is an oral, brain-penetrant small-molecule inhibitor of PI3K and mTOR. Because these two targets alter tumor vascularity and metabolism, respectively, we hypothesized multiparametric MR-PET could be used to quantify the response, estimate pharmacokinetic (PK) parameters, and predict progression-free survival (PFS) in patients with recurrent malignant gliomas. Multiparametric advanced MR-PET imaging was performed to evaluate physiologic response in a first-in-man, multicenter, phase I, dose-escalation study of GDC-0084 (NCT01547546) in 47 patients with recurrent malignant glioma. Measured maximum concentration ( Results from this study suggest composite biomarkers created from multiparametric MR-PET imaging targeting metabolic and/or physiologic processes specific to the drug mechanism of action may be useful for subsequent evaluation of treatment efficacy for larger phase II-III studies.

Identifiants

DOI: 10.1158/1078-0432.CCR-19-3817 PMID: 32269051 PMC: PMC8204664
pubmed: 32269051
pii: 1078-0432.CCR-19-3817
doi: 10.1158/1078-0432.CCR-19-3817
pmc: PMC8204664
mid: NIHMS1583662
doi:

Substances chimiques

Oxazines 0
Protein Kinase Inhibitors 0
Pyrimidines 0
GDC-0084 P5DKZ70636

Banques de données

ClinicalTrials.gov
['NCT01547546']

Types de publication

Clinical Trial, Phase I Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

3135-3144

Subventions

Organisme : NCI NIH HHS
ID : P50 CA211015
Pays : United States
Organisme : NCI NIH HHS
ID : R21 CA223757
Pays : United States

Informations de copyright

©2020 American Association for Cancer Research.

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Auteurs

Benjamin M Ellingson (BM)

UCLA Brain Tumor Imaging Laboratory (BTIL), Center for Computer Vision and Imaging Biomarkers, University of California, Los Angeles, Los Angeles, California. bellingson@mednet.ucla.edu.
Department of Radiological Sciences, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.
Department of Bioengineering, Henry Samueli School of Engineering and Applied Science, University of California, Los Angeles, Los Angeles, California.
Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.
Brain Research Institute, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.
UCLA Neuro-Oncology Program, University of California, Los Angeles, Los Angeles, California.
ORCID: 0000-0002-2764-6640

Jingwen Yao (J)

UCLA Brain Tumor Imaging Laboratory (BTIL), Center for Computer Vision and Imaging Biomarkers, University of California, Los Angeles, Los Angeles, California.
Department of Radiological Sciences, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.
Department of Bioengineering, Henry Samueli School of Engineering and Applied Science, University of California, Los Angeles, Los Angeles, California.

Catalina Raymond (C)

UCLA Brain Tumor Imaging Laboratory (BTIL), Center for Computer Vision and Imaging Biomarkers, University of California, Los Angeles, Los Angeles, California.
Department of Radiological Sciences, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.

David A Nathanson (DA)

Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.

Ararat Chakhoyan (A)

UCLA Brain Tumor Imaging Laboratory (BTIL), Center for Computer Vision and Imaging Biomarkers, University of California, Los Angeles, Los Angeles, California.
Department of Radiological Sciences, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.

Jeremy Simpson (J)

Kazia Therapeutics Limited, Sydney, New South Wales, Australia.

James S Garner (JS)

Kazia Therapeutics Limited, Sydney, New South Wales, Australia.

Alan G Olivero (AG)

Genentech, Inc., South San Francisco, California.

Lars U Mueller (LU)

Genentech, Inc., South San Francisco, California.

Jordi Rodon (J)

Vall d'Hebron Institute of Oncology, Barcelona, Spain.

Elizabeth Gerstner (E)

Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts.

Timothy F Cloughesy (TF)

UCLA Neuro-Oncology Program, University of California, Los Angeles, Los Angeles, California.
Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.

Patrick Y Wen (PY)

Center for Neuro-Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.

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