Introduction
Materials and methods
Patients
Study design
Statistical analysis
Results
Patient population
All patients (N = 35) | |
---|---|
Sex, n (%) | |
Female | 17 (49) |
Male | 18 (51) |
Age | |
Median | 62.0 |
Min, max | 31, 83 |
Age group, n (%) | |
<65 years | 23 (66) |
≥65 years | 12 (34) |
≥75 years | 4 (11) |
ECOG PS, n (%) | |
0 | 24 (69) |
1 | 9 (26) |
2 | 2 (6) |
Site of primary tumor at diagnosis, n (%) | |
Small intestine | 17 (49) |
Stomach | 10 (29) |
Colon | 2 (6) |
Rectum | 2 (6) |
Outcome measures
All patients (N = 35) | |
---|---|
Patients with measurable disease at baseline | 34 (97) |
Response assessment, n (%) | |
Confirmed CR | 0 (0) |
Confirmed PR | 1 (3) |
SDa
| 19 (54) |
PD | 13 (37) |
Unevaluableb
| 1 (3) |
Not done | 1 (3) |
Confirmed objective response (CR or PR) | 1 (3) |
95% CIc
| 0.1–14.9 |
Durable SDd
| 7 (20) |
Safety and tolerability
Preferred term | Number of patients reporting TRAE, n (%), 35 (100) | All patients (N = 35) | ||
---|---|---|---|---|
Grade 1/2 | Grade 3 | Grade 4 | All grades | |
Anemia | 1 (3) | 2 (6) | 0 (0) | 3 (9) |
Hypertension | 17 (48) | 5 (14) | 0 (0) | 22 (63) |
Diarrhea | 18 (51) | 0 (0) | 0 (0) | 18 (51) |
Fatigue | 13 (38) | 2 (6) | 0 (0) | 15 (43) |
Headache | 11 (31) | 0 (0) | 0 (0) | 11 (31) |
Weight decreased | 11 (31) | 0 (0) | 0 (0) | 11 (31) |
Rash | 10 (29) | 0 (0) | 0 (0) | 10 (29) |
Anorexia | 5 (14) | 4 (11) | 0 (0) | 9 (26) |
Nausea | 8 (23) | 1 (3) | 0 (0) | 9 (26) |
Blood thyroid-stimulating hormone increased | 8 (23) | 0 (0) | 0 (0) | 8 (23) |
Dysphonia | 8 (23) | 0 (0) | 0 (0) | 8 (23) |
Protein urine present | 6 (17) | 1 (3) | 0 (0) | 7 (20) |
Dry skin | 6 (17) | 0 (0) | 0 (0) | 6 (17) |
Vomiting | 5 (15) | 1 (3) | 0 (0) | 6 (17) |
PK parameter |
N
| Day 1 Mean ± SD | Day 29 Mean ± SD | Day 29:Day 1 ratio Mean ± SD |
---|---|---|---|---|
All evaluable patients | ||||
tmax (h)a | 10 | 0.75 (0.25–2.0) | 0.79 (0.50–4.0) | NA |
Cmax (ng/ml) | 10 | 800 ± 439 | 488 ± 363 | 0.62 ± 0.20 |
AUC0–24 (μg h/ml) | 9 | 3.87 ± 2.28 | 2.51 ± 2.10 | 0.71 ± 0.32 |
AUC0–inf (μg h/ml) | 9 | 4.14 ± 2.47 | NA | NA |
t1/2,z
(h) | 8 | 5.42 ± 1.51 | 4.27 ± 1.26 | NA |
CL/F (l/h) | 9 | 41.1 ± 22.3 | 69.3 ± 31.8 | NA |
C24 (ng/ml) | 9 | 27.6 ± 23.8 | 12.9 ± 15.4 | 0.80b ± 1.17 |
Evaluable patients with no prior gastrectomy | ||||
tmax (h)a | 6 | 1.0 (0.25–2.0) | 1.0 (0.50–4.0) | NA |
Cmax (ng/ml) | 6 | 692 ± 312 | 354 ± 193 | 0.53 ± 0.16 |
AUC0–24 (μg h/ml) | 5 | 3.91 ± 2.43 | 1.93 ± 0.67 | 0.67 ± 0.39 |
AUC0–inf (μg h/ml) | 5 | 4.27 ± 2.73 | NA | NA |
t1/2,z
(h) | 4 | 5.20 ± 1.79 | 4.32 ± 1.89 | NA |
CL/F (l/h) | 5 | 40.7 ± 24.5 | 71.5 ± 26.0 | NA |
C24 (ng/ml) | 5 | 33.5 ± 31.1 | 16.6 ± 20.3 | 1.11b ± 1.57 |
Evaluable patients with partial or full gastrectomy | ||||
tmax (h)a | 4 | 0.50 (0.25–2.0) | 0.50 (0.50–1.0) | NA |
Cmax (ng/ml) | 4 | 962 ± 599 | 689 ± 492 | 0.75 ± 0.21 |
AUC0–24 (μg h/ml) | 4 | 3.82 ± 2.45 | 3.23 ± 3.16 | 0.75 ± 0.25 |
AUC0–inf (μg h/ml) | 4 | 3.99 ± 2.49 | NA | NA |
t1/2,z
(h) | 4 | 5.63 ± 1.42 | 4.22 ± 0.38 | NA |
CL/F (l/h) | 4 | 41.6 ± 22.9 | 66.4 ± 42.2 | NA |
C24 (ng/ml) | 4 | 20.2 ± 9.2 | 8.37 ± 6.24 | 0.40 ± 0.16 |