Clinical development of nintedanib for advanced non-small-cell lung cancer

Figures & data

Table 1 Number of patients with DLTs (among evaluable patients) during the first course of nintedanib monotherapy in Phase I studies based in Germany¹³ and Japan¹⁴

Nintedanib dose (mg)	Germanyb		Japanb
	Once daily	Twice daily	Twice daily
50	0/2	N/A	N/A
100	0/1	N/A	N/A
150	N/A	0/6	0/3
150+200	N/A	0/6	N/A
200	1/8 (hepatotoxicity)	1/6 (decline in CD4^+ lymphocytes)	3/12a (hepatotoxicity)
250	1/6a (decline in CD4^+ lymphocytes)	1/13a (nausea)	3/6 (hepatotoxicity)
300	2/5 (hepatotoxicity)	4/5 (one with nausea and vomiting; one with decline in CD4^+ lymphocytes and hepatotoxicity; and two with hepatotoxicity)	N/A
450	2/3 (hepatotoxicity)	N/A	N/A

Notes:

a MTD.

b Data present as the number of patients with DLTs/number of patients eligible for evaluation of DLTs.

Abbreviations: DLTs, dose-limiting toxicities; MTD, maximum tolerated dose; N/A, not applicable.

Table 2 Number of patients with DLTs (among evaluable patients) during the first course of nintedanib combination therapy in Phase I studies based in North America¹⁷ and Japan²¹

Nintedanib dose (mg bid)	North Americab	Japanb
	With pemetrexed (500 mg/m^2)	With docetaxel (60 mg/m^2)		With docetaxel (75 mg/m^2)
100	1/6	0/3	N/A	N/A	N/A
150	1/6	2/6 (BSA <1.5 m^2)	0/3 (BSA ≥1.5 m^2)	1/6 (BSA <1.5 m^2)a	2/6 (BSA ≥1.5 m^2)
200	3/12a	3/3 (BSA <1.5 m^2)	2/6 (BSA ≥1.5 m^2)	N/A	2/6 (BSA ≥1.5 m^2)a
250	2/2	N/A	N/A	N/A	N/A

Notes:

a MTD.

b Data present as the number of patients with DLTs/number of patients eligible for evaluation of DLTs.

Abbreviations: DLTs, dose-limiting toxicities; MTD, maximum tolerated dose; BSA, body surface area; N/A, not applicable.

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