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Table 2 Selected trials of oncology drugs in healthy volunteers.

From: Reviewing the role of healthy volunteer studies in drug development

NCT number

Treatment

Target/MOA

Study design

Outcomes

Study population

Enrolled (N)

Completed clinical trials

 NCT00658554

ARQ 197

c-MET inhibitor

Randomized, open-label, crossover

PK, safety

Healthy volunteers

24

 NCT02474537

INC280 (capmatinib)

c-MET inhibitor

Open-label, parallel-group, two-staged, single-dose

PK, safety

Subjects with impaired hepatic function; healthy subjects with normal hepatic function

31

 NCT03154086

GSK3352589

RET growth factor receptor TKI

Randomized, double-blind, crossover, placebo-controlled, single- and repeat-dose escalation

Safety, PK

Healthy volunteers

59

 NCT03192111

Entinostat

HDAC inhibitor

Open-label, parallel-cohort, single-dose

PK, safety, tolerability

Adults subjects with mild, moderate, severe renal impairment; healthy volunteers

40

 NCT00418626

Nilotinib (AMN107)

TKI

Open-label, single-dose,

PK, impact on hepatic function

Subjects with impaired hepatic function; healthy subjects with normal hepatic function

27

 NCT02388620

LEE011 (ribociclib)

CDK4/6 inhibitor

Open-label, parallel-cohort, single-dose

PK, safety

Subjects with impaired hepatic function; healthy subjects with normal hepatic function

30

 NCT01764776

LDE225 (sonidegib)

Smo antagonist

Open-label, single-dose

PK, safety

Subjects with impaired hepatic function; healthy subjects with normal hepatic function

33

 NCT02050815

MEK162 (binimetinib)

MEK inhibitor

Open-label, single-dose

PK, safety

Subjects with impaired hepatic function; healthy subjects with normal hepatic function

27

 NCT02621047

Alectinib

ALK inhibitor

Open-label, single-dose, parallel assignment

Effect of hepatic impairment on PK

Subjects with hepatic impairment; healthy subjects with normal hepatic function

28

 NCT01901133

MDV3100 (enzalutamide)

AR antagonist

Open-label, single-dose, parallel assignment

PK, safety

Male subjects with mild or moderate hepatic impairment; male subjects with normal hepatic function

33

Ongoing clinical trials

 NCT02922946 (not yet recruiting)

Entinostat

HDAC inhibitor

Open-label, randomized, single-dose, crossover

Effect of food on PK

Healthy subjects

48

 NCT02431481 (ongoing)

LEE011 (ribociclib)

CDK4/6 inhibitor

Open-label, parallel-group, single-dose

PK, safety

Subjects with varying degrees of impaired renal function; healthy volunteers with normal renal function

64

 NCT02852239 (ongoing)

Dabrafenib

BRAF inhibitor

Open-label, single-dose

PK, safety

Subjects with impaired renal function; healthy subjects with normal renal function

~ 32

 NCT02852239 (ongoing)

Dabrafenib

BRAF inhibitor

Open-label, single-dose

PK, safety

Subjects with impaired hepatic function; healthy subjects with normal hepatic function

~ 32

  1. ALK, anaplastic lymphoma kinase; AR, androgen receptor; BRAF, v-raf murine sarcoma viral oncogene homolog B1; CDK4/6, cyclin-dependent kinases 4 and 6; HDAC, histone deacetylase; MOA, mechanism of action; PK, pharmacokinetics; TKI, tyrosine kinase inhibitor