Phase II study of amrubicin plus erlotinib in previously treated, advanced non-small cell lung cancer with wild-type epidermal growth factor receptor (TORG1320)

Summary Background Amrubicin (AMR) is a completely synthetic 9-aminoanthracycline and clinically active against non-small cell lung cancer (NSCLC). We conducted a phase I study of AMR and erlotinib (ERL) combination therapy in previously treated patients with advanced NSCLC and have already reported...

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Veröffentlicht in:	Investigational new drugs 2021-04, Vol.39 (2), p.530-536
Hauptverfasser:	Otani, Sakiko, Sasaki, Jiichiro, Nakahara, Yoshiro, Fukui, Tomoya, Igawa, Satoshi, Naoki, Katsuhiko, Bessho, Akihiro, Hosokawa, Shinobu, Fukamatsu, Nobuaki, Nakamura, Yukiko, Kasai, Takashi, Sugiyama, Tomohide, Tokito, Takaaki, Seki, Nobuhiko, Hamada, Akinobu, Okamoto, Hiroaki, Masuda, Noriyuki
Format:	Artikel
Sprache:	eng
Schlagworte:	Adult Aged Anthracyclines - administration & dosage Anthracyclines - adverse effects Anthracyclines - pharmacokinetics Anthracyclines - therapeutic use Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Antineoplastic Agents - pharmacokinetics Antineoplastic Agents - therapeutic use Antineoplastic Combined Chemotherapy Protocols - therapeutic use c-Met protein Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - genetics Combination therapy Confidence intervals Disease control Epidermal growth factor Epidermal growth factor receptors ErbB Receptors - genetics Erlotinib Hydrochloride - administration & dosage Erlotinib Hydrochloride - adverse effects Erlotinib Hydrochloride - pharmacokinetics Erlotinib Hydrochloride - therapeutic use Growth factors Health services Humans Inhibitor drugs Lung cancer Lung Neoplasms - drug therapy Lung Neoplasms - genetics Male Medicine Medicine & Public Health Middle Aged Mutation Non-small cell lung carcinoma Oncology Patients Pharmacokinetics Pharmacology Pharmacology/Toxicology Phase II Studies Progression-Free Survival Safety Small cell lung carcinoma Targeted cancer therapy Therapy Toxicity
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Zusammenfassung:	Summary Background Amrubicin (AMR) is a completely synthetic 9-aminoanthracycline and clinically active against non-small cell lung cancer (NSCLC). We conducted a phase I study of AMR and erlotinib (ERL) combination therapy in previously treated patients with advanced NSCLC and have already reported the safety and effectiveness. Methods We conducted a multi-center, single-arm phase II trial to evaluate the efficacy of AMR and ERL combination therapy in patients with previously treated, advanced NSCLC harboring wild-type EGFR, PS 0–1 and
ISSN:	0167-6997 1573-0646
DOI:	10.1007/s10637-020-01031-z