|
Navoximod 50 mg BID (n = 1)
|
Navoximod 100 mg BID (n = 3)
|
Navoximod 200 mg BID (n = 3)
|
Navoximod 400 mg BID (n = 3)
|
Navoximod 600 mg BID (n = 3)
|
Navoximod 800 mg BID (n = 6)
|
All Patients 21/28 day schedule (N = 19)
|
Navoximod continuous schedule 600 mg BID (n = 3)
|
All Patients (N = 22)
|
---|
Any adverse event
|
1 (100%)
|
3 (100%)
|
3 (100%)
|
3 (100%)
|
3 (100%)
|
6 (100%)
|
19 (100%)
|
3 (100%)
|
22 (100%)
|
Fatigue
|
1 (100%)
|
2 (67%)
|
3 (100%)
|
1 (33%)
|
1 (33%)
|
3 (50%)
|
11 (58%)
|
2 (67%)
|
13 (59%)
|
Cough
|
1 (100%)
|
3 (100%)
|
–
|
–
|
1 (33%)
|
4 (67%)
|
9 (47%)
|
–
|
9 (40%)
|
Decreased appetite
|
1 (100%)
|
2 (67%)
|
3 (100%)
|
–
|
–
|
3 (50%)
|
9 (47%)
|
–
|
9 (40%)
|
Pruritus
|
–
|
2 (67%)
|
2 (67%)
|
1 (33%)
|
2 (67%)
|
1 (17%)
|
8 (42%)
|
1 (33%)
|
9 (40%)
|
Nausea
|
1 (100%)
|
3 (100%)
|
–
|
1 (33%)
|
1 (33%)
|
2 (67%)
|
8 (42%)
|
–
|
8 (36%)
|
Vomiting
|
–
|
1 (33%)
|
1 (33%)
|
1 (33%)
|
1 (33%)
|
1 (17%)
|
5 (26%)
|
1 (33%)
|
6 (27%)
|
Anxiety
|
1 (100%)
|
1 (33%)
|
1 (33%)
|
–
|
–
|
1 (17%)
|
4 (21%)
|
–
|
4 (18%)
|
AST increased
|
–
|
–
|
1 (33%)
|
1 (33%)
|
–
|
2 (33%)
|
4 (21%)
|
–
|
4 (18%)
|
Constipation
|
–
|
–
|
2 (67%)
|
–
|
–
|
2 (33%)
|
4 (21%)
|
–
|
4 (18%)
|
Dyspepsia
|
–
|
–
|
2 (67%)
|
2 (67%)
|
–
|
–
|
4 (21%)
|
–
|
4 (18%)
|
Dyspnea
|
1 (100%)
|
1 (33%)
|
–
|
–
|
–
|
2 (33%)
|
4 (21%)
|
–
|
4 (18%)
|
Wheezing
|
1 (100%)
|
1 (33%)
|
–
|
–
|
1 (33%)
|
1 (17%)
|
4 (21%)
|
–
|
4 (18%)
|
Rash terms a
|
–
|
1 (33%)
|
–
|
1 (33%)
|
1 (33%)
|
1 (33%)
|
4 (21%)
|
1 (33%)
|
5 (23%)
|
Abdominal pain
|
–
|
2 (67%)
|
–
|
–
|
–
|
1 (17%)
|
3 (16%)
|
1 (33%)
|
4 (18%)
|
Hypokalemia
|
1 (100%)
|
–
|
–
|
–
|
1 (33%)
|
1 (17%)
|
3 (16%)
|
1 (33%)
|
4 (18%)
|
Ascites
|
–
|
–
|
–
|
1 (33%)
|
1 (33%)
|
1 (17%)
|
3 (16%)
|
–
|
3 (14%)
|
Neoplasm progression
|
–
|
–
|
1 (33%)
|
1 (33%)
|
1 (33%)
|
–
|
3 (16%)
|
–
|
3 (14%)
|
Upper respiratory tract infection
|
–
|
1 (33%)
|
1 (33%)
|
–
|
–
|
1 (17%)
|
3 (16%)
|
–
|
3 (14%)
|
Dry mouth
|
–
|
–
|
–
|
–
|
2 (67%)
|
–
|
2 (11%)
|
1 (33%)
|
3 (14%)
|
- aRash terms = rash and rash maculopapular