Phase I trial of copanlisib, a selective PI3K inhibitor, in combination with cetuximab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma.
Aged
Antineoplastic Agents
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Area Under Curve
Cetuximab
/ therapeutic use
Dose-Response Relationship, Drug
Female
Half-Life
Head and Neck Neoplasms
/ drug therapy
Humans
Male
Maximum Tolerated Dose
Middle Aged
Phosphoinositide-3 Kinase Inhibitors
/ administration & dosage
Pyrimidines
/ administration & dosage
Quinazolines
/ administration & dosage
Squamous Cell Carcinoma of Head and Neck
/ drug therapy
Cetuximab
Copanlisib
EGFR
Head and neck cancer
Phase I
Phosphatidylinositol-3 kinase (PI3K)
Journal
Investigational new drugs
ISSN: 1573-0646
Titre abrégé: Invest New Drugs
Pays: United States
ID NLM: 8309330
Informations de publication
Date de publication:
12 2021
12 2021
Historique:
received:
13
06
2021
accepted:
12
07
2021
pubmed:
30
7
2021
medline:
17
2
2022
entrez:
29
7
2021
Statut:
ppublish
Résumé
Background The phosphatidylinositol-3 kinase pathway is often altered in head and neck squamous cell carcinoma (HNSCC), and is involved in the resistance to EGFR inhibitors. Objective We investigated the dose-limiting toxicities (DLTs), maximum tolerated dose, pharmacokinetics, and preliminary efficacy of the combination of copanlisib, an intravenous, pan-class I PI3K inhibitor, with the anti-EGFR monoclonal antibody cetuximab in recurrent and/or metastatic HNSCC patients in a phase I dose-escalation trial. Patients and methods Copanlisib was given intravenously on days 1, 8, and 15 of 28-day cycles at the dose of 45 mg and 30 mg, in combination with standard doses of weekly cetuximab (400 mg/m
Identifiants
pubmed: 34322775
doi: 10.1007/s10637-021-01152-z
pii: 10.1007/s10637-021-01152-z
doi:
Substances chimiques
Antineoplastic Agents
0
Phosphoinositide-3 Kinase Inhibitors
0
Pyrimidines
0
Quinazolines
0
Cetuximab
PQX0D8J21J
copanlisib
WI6V529FZ9
Banques de données
ClinicalTrials.gov
['NCT02822482']
Types de publication
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1641-1648Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
Références
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