A phase 1b study evaluating the safety and pharmacokinetics of regorafenib in combination with cetuximab in patients with advanced solid tumors.
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Cetuximab
/ adverse effects
Drug Interactions
/ physiology
Female
Humans
Male
Maximum Tolerated Dose
Middle Aged
Neoplasms
/ drug therapy
Phenylurea Compounds
/ adverse effects
Pyridines
/ adverse effects
Treatment Outcome
Young Adult
cetuximab
metastatic colorectal cancer
phase 1
regorafenib
Journal
International journal of cancer
ISSN: 1097-0215
Titre abrégé: Int J Cancer
Pays: United States
ID NLM: 0042124
Informations de publication
Date de publication:
01 11 2019
01 11 2019
Historique:
received:
26
10
2018
revised:
29
01
2019
accepted:
27
02
2019
pubmed:
9
4
2019
medline:
25
1
2020
entrez:
9
4
2019
Statut:
ppublish
Résumé
Regorafenib 160 mg orally once daily (QD) 3 weeks on/1 week off is approved in colorectal cancer, gastrointestinal stromal tumors and hepatocellular carcinoma. We established the safety and pharmacokinetics (PK) of regorafenib combined with cetuximab in advanced refractory solid tumors. This was a phase 1, open-label, dose-escalation study (NCT01973868) in patients with advanced/metastatic solid tumors who progressed after standard therapy. Regorafenib was administered at various dose levels QD continuously or intermittently (3 weeks on/1 week off) combined with intravenous cetuximab 250 mg/m
Identifiants
pubmed: 30958892
doi: 10.1002/ijc.32317
pmc: PMC6771657
doi:
Substances chimiques
Phenylurea Compounds
0
Pyridines
0
regorafenib
24T2A1DOYB
Cetuximab
PQX0D8J21J
Banques de données
ClinicalTrials.gov
['NCT01973868']
Types de publication
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2450-2458Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR001855
Pays : United States
Informations de copyright
© 2019 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.
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