Baseline characteristic
|
Study 1
|
Study 2a
|
---|
|
V930 DNA-EP
|
V930 DNA-EP
|
V932 Ad
|
V932 Ad
|
---|
|
0.25 mg
|
2.5 mg
|
0.5 × 109vg/injection
|
0.5 × 1011vg/injection
|
---|
|
(n=6)
|
(n=22)
|
(n=6)
|
(n=5)
|
---|
Age, years (mean ± SD)
|
66.8 ± 9.2
|
58.6 ± 15.9
|
58.8 ± 12.9
|
54.4 ± 8.6
|
Gender, n (%)
| | | | |
Male
|
2 (33)
|
8 (36)
|
2 (33)
|
4 (80)
|
Female
|
4 (67)
|
14 (64)
|
4 (67)
|
1 (20)
|
Race, n (%)
| | | | |
White
|
6 (100)
|
21 (96)
|
5 (83)
|
5 (100)
|
Other
|
0
|
1 (4.5)
|
1 (16.7)
|
0
|
KPS, n (%)
| | | | |
100
|
6 (100)
|
17 (77)
|
6 (100)
|
5 (100)
|
90
|
0
|
5 (23)
|
0
|
0
|
Tumor diagnosis, n (%)
| | | | |
Adenocarcinoma NOS
|
1 (17)
|
1 (5)
|
0
|
0
|
Breast cancer
|
0
|
7 (32)
|
3 (50)
|
0
|
Colorectal cancer
|
4 (67)
|
6 (27)
|
1 (17)
|
1 (20)
|
Non-small cell lung cancer
|
1 (17)
|
5 (23)
|
2 (33)
|
1 (20)
|
Ovarian cancer
|
0
|
1 (5)
|
0
|
0
|
Pancreatic cancer
|
0
|
1 (5)
|
0
|
0
|
Squamous cell carcinoma
|
0
|
1 (5)
|
0
|
0
|
NOS
|
0
|
0
|
0
|
1 (20)
|
Renal cancer
|
0
|
0
|
0
|
2 (40)
|
Bladder cancer
|
0
|
0
|
0
|
1 (20)
|
Prior lines of chemotherapy, n (%)
| | | | |
0
|
0
|
0
|
0
|
1 (20)
|
1
|
6 (100)
|
11 (50)
|
2 (33)
|
1 (20)
|
2
|
0
|
5 (23)
|
3 (50)
|
1 (20)
|
≥3
|
0
|
6 (27)
|
1 (17)
|
2 (40)
|
Stage IV cancer
|
0 (0)
|
11 (50)
|
4 (67)
|
3 (60)
|
- aSix eligible patients from Study 1 were enrolled into Study 2. Therefore, only 5 patients that had not previously participated in Study 1 were enrolled into Study 2. Overall 33 patients (not 39) were enrolled in both studies.
- KPS: Karnofsky performance status; NOS, not otherwise specified; SD, standard deviation.