Erlotinib in Combination With Select Tyrosine Kinase Inhibitors in Adult Patients With Advanced Solid Tumors : Phase 1 Umbrella Trial of Erlotinib In Combination With Select Tyrosine Kinase Inhibitors In Adult Patients With Advanced Solid Tumors

Primary Objective:-To establish the safety, tolerability, and maximum tolerated dose (MTD) of the erlotinib-lenvatinib and erlotinib-axitinib combinations in adult patients with advanced solid tumorsSecondary Objective:-To evaluate the plasma pharmacokinetic profiles of erlotinib and either lenvatinib or axitinib when used in combinationExploratory Objectives:To assess the preliminary antitumor activity of the erlotinib-lenvatinib and erlotinib-axitinib combinations in patients with advanced solid tumorsTo examine changes in numbers of circulating tumor cells (CTCs) of epithelial (cytokeratin+) or mesenchymal (vimentin+) phenotype in response to the erlotinib-lenvatinib or erlotinib-axitinib combinationsTo examine genomic alterations in circulating tumor DNA (ctDNA) that may be associated with response or resistance to the erlotinib-lenvatinib or erlotinib-axitinib combinationStudy Design:This is an open-label, 2-arm phase 1 trial.All agents will be administered orally in 28-day cycles. Dose escalation on both arms will follow a 3 plus 3 design, with intrapatient dose escalation permitted.Assignment to one of the treatment arms will be determined by the study.The study will allow accrual of patients to backfill cohorts, in which patients will be enrolled on the most recently cleared dose level when accrual to the current dose level has been completed per 3 plus 3 design, but the DLT monitoring period has yet to be completed at that dose level. Dose-limiting toxicities will be defined during the first cycle of treatment.The accrual ceiling will be set at 70 patients..

Medienart:	Klinische Studie

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	ClinicalTrials.gov - (2024) vom: 02. Apr. Zur Gesamtaufnahme - year:2024

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Phase: Phase 1 Recruitment Status: Not yet recruiting Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: December 8, 2023, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024

Study ID:

NCT06161558 10001657 001657-C

Veröffentlichungen zur Studie:

Kummar S, Chen HX, Wright J, Holbeck S, Millin MD, Tomaszewski J, Zweibel J, Collins J, Doroshow JH. Utilizing targeted cancer therapeutic agents in combination: novel approaches and urgent requirements. Nat Rev Drug Discov. 2010 Nov;9(11):843-56. doi: 10.1038/nrd3216. Epub 2010 Oct 29. Conradt L, Godl K, Schaab C, Tebbe A, Eser S, Diersch S, Michalski CW, Kleeff J, Schnieke A, Schmid RM, Saur D, Schneider G. Disclosure of erlotinib as a multikinase inhibitor in pancreatic ductal adenocarcinoma. Neoplasia. 2011 Nov;13(11):1026-34. doi: 10.1593/neo.111016. Augustin A, Lamerz J, Meistermann H, Golling S, Scheiblich S, Hermann JC, Duchateau-Nguyen G, Tzouros M, Avila DW, Langen H, Essioux L, Klughammer B. Quantitative chemical proteomics profiling differentiates erlotinib from gefitinib in EGFR wild-type non-small cell lung carcinoma cell lines. Mol Cancer Ther. 2013 Apr;12(4):520-9. doi: 10.1158/1535-7163.MCT-12-0880. Epub 2013 Jan 31.

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PPN (Katalog-ID):	CTG000014125