An open-label feasibility study of nintedanib combined with docetaxel in Japanese patients with locally advanced or metastatic lung adenocarcinoma after failure of first-line chemotherapy

Abstract

Purpose

This open-label feasibility study assessed the tolerability of nintedanib 200 mg in combination with docetaxel 75 mg/m² as a starting dose in Japanese patients with a body surface area (BSA) < 1.5 m² and locally advanced or metastatic lung adenocarcinoma.

Methods

Eligible patients received docetaxel 75 mg/m² every 21 days and nintedanib administered at 200 mg twice daily (bid), starting on day 2 of each cycle. Treatment was continued until disease progression or undue toxicity. The primary endpoint was the number of patients experiencing dose-limiting toxicities (DLTs) in cycle 1 (days 1–21).

Results

Of 10 treated patients, 2 patients (20%) experienced DLTs during cycle 1. These DLTs were grade 3 liver enzyme elevations [alanine aminotransferase (2 patients) and aspartate aminotransferase (2 patients)], and grade 2 hyperbilirubinemia (1 patient). Nine patients met the predefined criteria for nintedanib 200 mg bid plus docetaxel 75 mg/m² to be considered a tolerable starting dose. All patients experienced ≥ 1 adverse event (AE) during the treatment period (all drug-related), but no patients experienced AEs that led to discontinuation of nintedanib. Of the five serious AEs reported during treatment, none were drug-related. There was no apparent effect of nintedanib on the pharmacokinetics of docetaxel. The objective response and disease control rates were 40 and 70%, respectively.

Conclusion

Nintedanib 200 mg bid plus docetaxel 75 mg/m² is a tolerable starting dose in Japanese patients with a BSA < 1.5 m² with locally advanced or metastatic lung adenocarcinoma.

ClinicalTrials.gov number

NCT02300298.

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