Tolerability of Nintedanib (BIBF 1120) in Combination with Docetaxel: A Phase 1 Study in Japanese Patients with Previously Treated Non–Small-Cell Lung.

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Tolerability of Nintedanib (BIBF 1120) in Combination with Docetaxel: A Phase 1 Study in Japanese Patients with Previously Treated Non–Small-Cell Lung Cancer Isamu Okamoto, MD, PhD, Masaki Miyazaki, MD, PhD, Masayuki Takeda, MD, PhD, Masaaki Terashima, MD, PhD, Koichi Azuma, MD, PhD, Hidetoshi Hayashi, MD, PhD, Hiroyasu Kaneda, MD, PhD, Takayasu Kurata, MD, PhD, Junji Tsurutani, MD, PhD, Takashi Seto, MD, PhD, Fumihiko Hirai, MD, PhD, Koichi Konishi, BPharm, Akiko Sarashina, MSc, Nobutaka Yagi, MSc, Rolf Kaiser, MD, Kazuhiko Nakagawa, MD, PhD Journal of Thoracic Oncology Volume 10, Issue 2, Pages 346-352 (February 2015) DOI: 10.1097/JTO.0000000000000395 Copyright © 2015 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 1 Patient flow. N100/D60, nintedanib 100 mg bid plus docetaxel 60 mg/m2; N150/D60, nintedanib 150 mg bid plus docetaxel 60 mg/m2; N150/D75, nintedanib 150 mg bid plus docetaxel 75 mg/m2; N200/D60, nintedanib 200 mg bid plus docetaxel 60 mg/m2; N200/D75, nintedanib 200 mg bid plus docetaxel 75 mg/m2. aProtocol amendment by the Efficacy and Safety Review Committee, which recommended separate assessments of dose levels for patients with a body surface area (BSA) <1.5 m2 and ≥1.5 m2. bOne patient was replaced due to low compliance with study drugs administration with a non-dose-limiting toxicity adverse event (pneumonia). cOne patient was replaced due to insufficient data to evaluate the duration of grade 4 neutropenia as a dose-limiting toxicity. dOne patient was replaced due to early withdrawal of consent. Journal of Thoracic Oncology 2015 10, 346-352DOI: (10.1097/JTO.0000000000000395) Copyright © 2015 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 2 Change in alanine aminotransferase (ALT) values in all eight patients with dose reduction on nintedanib by dose-limiting toxicity (DLT) during first treatment course and nintedanib treatment days. BSA, body surface area. Journal of Thoracic Oncology 2015 10, 346-352DOI: (10.1097/JTO.0000000000000395) Copyright © 2015 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 3 Cmax, norm (A), AUC0–12, norm (B), and AUC0–∞, norm (C) of nintedanib following single oral administration of nintedanib 100, 150, or 200 mg in patients with a body surface area <1.5 m2 or ≥1.5 m2. AUC0–∞, norm, dose-normalized area under the concentration–time curve (0–∞ hours); AUC0–12, norm, dose-normalized area under the concentration–time curve (0–12 hours); Cmax, norm, dose-normalized peak concentration; gMean, geometric mean; BSA, body surface area. Journal of Thoracic Oncology 2015 10, 346-352DOI: (10.1097/JTO.0000000000000395) Copyright © 2015 International Association for the Study of Lung Cancer Terms and Conditions