Table 3.

Clinical trials focusing on PLK1 inhibition based combination therapy.

Disease	Phase	Patient's condition	Number of patients enrolled	Plk1 inhibitor			The other inhibitor			Cycle (days)	Efficacy	Ref	NCT #
				Name	Dose	Administration	Name	Dose	Administration
Acute myeloid leukemia	II	Ineligible for intensive induction therapy	87	BI6727	350 mg BI6727 on days 1 and 15)	IV	LDAC	20 mg BID on days 1–10	SC	28	PFS: 2.3 month with LDAC; 5.6 months with combination	[79,80]	NCT01721876
Acute myeloid leukemia	I	Aged above 65, ineligible for intensive therapy	13	BI6727	300–400 mg on days 1 and 15	IV	Decitabine	20 mg/m2 on days 1–5	IV	28	2CR, 1PR	[83]	NCT02003573
Acute myeloid leukemia	I	ECOG Performance Status 0–2	23	NMS-1286937	12–60 mg/m2 on days 1–5	Oral	Decitabine	20 mg/m2 on days 1–5	IV	28	5CR	[13]	NCT03303339
Solid tumors	I	Advanced non-resectable and/or metastatic disease, failure of conventional treatment	57	BI6727	150–300 mg on day 1	IV	Afatinib	Schedule A: 30–50 mg on days 2–21 Schedule B: 50–90 mg on days 2–6	Oral	21	2PR, 8SD	[84]	NCT01206816
Solid tumors	I	Advanced, nonresectable and/or metastatic solid tumors	28	BI6727	300 mg on day 1	IV	Itraconazole	200 mg on days 1–18	Oral	21	25SD	[85]	NCT01772563
Solid tumors	I	Advanced metastatic solid tumors, failure of conventional treatment	30	BI6727	100–300 mg on day 8	IV	Nintedanib	200 mg BID days 1–7 and days 9–28	Oral	28	1 CR, 1 PR, 16 SD	[86]	NCT01022853
Non-small cell lung cancer	II	Recurrent, advanced, or metastatic NSCLC, progressed after platinum-based chemotherapy regimen	131	BI6727	250–300 mg on day 1	IV	Pemetrexed	500 mg/m2	IV	21	PFS: 5.3 months with pemetrexed; 1.4 months with BI6727; 3.3 months with combination	[87]	NCT00824408