https://scholars.lib.ntu.edu.tw/handle/123456789/629465
DC Field | Value | Language |
---|---|---|
dc.contributor.author | CHIH-HSIN YANG | en_US |
dc.contributor.author | Su, Wu-Chou | en_US |
dc.contributor.author | Chiu, Chao-Hua | en_US |
dc.contributor.author | Shiah, Her-Shyong | en_US |
dc.contributor.author | Lee, Kang-Yun | en_US |
dc.contributor.author | Hsia, Te-Chun | en_US |
dc.contributor.author | Uno, Makiko | en_US |
dc.contributor.author | Crawford, Nigel | en_US |
dc.contributor.author | Terakawa, Hiroshi | en_US |
dc.contributor.author | Chen, Wen-Chi | en_US |
dc.contributor.author | Takayama, Gensuke | en_US |
dc.contributor.author | Hsu, Ching | en_US |
dc.contributor.author | Hong, Ying | en_US |
dc.contributor.author | Saintilien, Carline | en_US |
dc.contributor.author | McGill, Joseph | en_US |
dc.contributor.author | Chang, Gee-Chen | en_US |
dc.date.accessioned | 2023-03-21T02:40:19Z | - |
dc.date.available | 2023-03-21T02:40:19Z | - |
dc.date.issued | 2023-03-09 | - |
dc.identifier.issn | 01676997 | - |
dc.identifier.uri | https://scholars.lib.ntu.edu.tw/handle/123456789/629465 | - |
dc.description.abstract | The objective of this study was to evaluate the safety and tolerability of DS-1205c, an oral AXL-receptor inhibitor, in combination with osimertinib in metastatic or unresectable EFGR-mutant non-small cell lung cancer (NSCLC) patients who developed disease progression during EGFR tyrosine kinase inhibitor (TKI) treatment. An open-label, non-randomized phase 1 study was conducted in Taiwan, in which 13 patients received DS-1205c monotherapy at a dosage of 200, 400, 800, or 1200 mg twice daily for 7 days, followed by combination treatment with DS-1205c (same doses) plus osimertinib 80 mg once daily in 21-day cycles. Treatment continued until disease progression or other discontinuation criteria were met. At least one treatment-emergent adverse event (TEAE) was reported in all 13 patients treated with DS-1205c plus osimertinib; with ≥ 1 grade 3 TEAE in 6 patients (one of whom also had a grade 4 increased lipase level), and 6 patients having ≥ 1 serious TEAE. Eight patients experienced ≥ 1 treatment-related AE (TRAE). The most common (2 cases each) were anemia, diarrhea, fatigue, increased AST, increased ALT, increased blood creatinine phosphokinase, and increased lipase. All TRAEs were non-serious, with the exception of an overdose of osimertinib in 1 patient. No deaths were reported. Two-thirds of patients achieved stable disease (one-third for > 100 days), but none achieved a complete or partial response. No association between AXL positivity in tumor tissue and clinical efficacy was observed. DS-1205c was well-tolerated with no new safety signals in patients with advanced EGFR-mutant NSCLC when administered in combination with the EFGR TKI osimertinib. ClinicalTrials.gov ; NCT03255083. | en_US |
dc.language.iso | en | en_US |
dc.relation.ispartof | Investigational new drugs | en_US |
dc.subject | AXL kinase inhibitor; Advanced non-small cell lung cancer; DS-1205c; Epidermal growth factor receptor; Inoperable non-small cell lung cancer; Oncology | en_US |
dc.title | Evaluation of combination treatment with DS-1205c, an AXL kinase inhibitor, and osimertinib in metastatic or unresectable EGFR-mutant non-small cell lung cancer: results from a multicenter, open-label phase 1 study | en_US |
dc.type | journal article | en |
dc.identifier.doi | 10.1007/s10637-023-01341-y | - |
dc.identifier.pmid | 36892745 | - |
dc.identifier.scopus | 2-s2.0-85149513197 | - |
dc.identifier.url | https://api.elsevier.com/content/abstract/scopus_id/85149513197 | - |
item.openairetype | journal article | - |
item.openairecristype | http://purl.org/coar/resource_type/c_6501 | - |
item.fulltext | no fulltext | - |
item.grantfulltext | none | - |
item.languageiso639-1 | en | - |
item.cerifentitytype | Publications | - |
crisitem.author.dept | Oncology | - |
crisitem.author.dept | Cancer Administration and Coordination Center | - |
crisitem.author.dept | National Taiwan University Cancer Center (NTUCC) | - |
crisitem.author.orcid | 0000-0002-5586-5138 | - |
crisitem.author.parentorg | College of Medicine | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
Appears in Collections: | 腫瘤醫學研究所 |
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