Patient disposition
A total of 32 patients were enrolled in the study. Of these, 26 patients
(81.3%) completed the DDI phase. The reasons for DDI phase
discontinuation were AEs (two patients [6.3%]), physician’s
decision (two patients [6.3%]), disease progression (one patient
[3.1%]) and death (one patient [3.1%], Table 1 ). Of
the two patients who discontinued the DDI phase due to AEs, one had
experienced Grade 3 blood bilirubin and Grade 4 encephalopathy (both
non-treatment related), and another patient had experienced Grade 3
abdominal pain and Grade 3 vomiting, both were treatment-related.
A total of 27 patients (84.4%) entered the treatment (post-DDI) phase,
all of whom discontinued the study; the primary reason for
discontinuation was PD (20 patients [62.5%]). Three patients
(9.4%) discontinued from the treatment phase (post-DDI) due to
physician decision and one patient each (3.1%, each) discontinued due
to AE (Grade 3 pulmonary embolism; non-treatment related) and being lost
to follow-up. Two patients (6.3%) died during the post-DDI phase; one
due to PD and another due to Grade 3 respiratory tract infection
(non-treatment related). One patient (3.1%) entered the post-treatment
follow-up phase. However, this patient was discontinued due to protocol
deviation. The patient received rosuvastatin during the DDI phase except
on Day 1 and Day 22. All 32 patients enrolled in the study were included
in the full analysis set and safety set. Of these, 25 (78.1%), 24
(75.0%), and 17 (53.1%) patients were included in pharmacokinetic
analysis set for digoxin, rosuvastatin, and capmatinib, respectively.