Table 2.
Demographic and baseline characteristics
| PF-06952229, mg | Part 1A, PF-06952229 monotherapy |
Part 1B, PF-06952229 plus Enza |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 20 n = 1 | 40 n = 1 | 80 n = 1 | 150 n = 5 | 250 n = 13 | 375 n = 17 | 500 n = 4 | Total n = 42 | 250 plus Enza n = 4 | 375 plus Enza n = 3 | Total n = 7 | |
| Age, years | |||||||||||
| 18-44 | 0 | 0 | 0 | 0 | 1 (7.7) | 0 | 0 | 1 (2.4) | 0 | 0 | 0 |
| 45-64 | 0 | 0 | 0 | 2 (40.0) | 2 (15.4) | 7 (41.2) | 0 | 11 (26.2) | 3 (75.0) | 1 (33.3) | 4 (57.1) |
| ≥65 | 1 (100.0) | 1 (100.0) | 1 (100.0) | 3 (60.0) | 10 (76.9) | 10 (58.8) | 4 (100.0) | 30 (71.4) | 1 (25.0) | 2 (66.7) | 3 (42.9) |
| Mean (SD) | 79 (—) | 74 (—) | 73 (—) | 65.6 (8.9) | 65.5 (12.9) | 67.7 (9.4) | 75.3 (2.5) | 68.0 (10.2) | 62.8 (6.0) | 65.3 (6.4) | 63.9 (5.8) |
| Median (range) | 79 (79-79) | 74 (74-74) | 73 (73-73) | 65 (53-75) | 69 (26-76) | 67 (54-88) | 76 (72-78) | 71 (26-88) | 62 (57-71) | 69 (58-69) | 63 (57-71) |
| Sex | |||||||||||
| Male | 1 (100.0) | 1 (100.0) | 1 (100.0) | 4 (80.0) | 10 (76.9) | 16 (94.1) | 4 (100.0) | 37 (88.1) | 4 (100.0) | 3 (100.0) | 7 (100.0) |
| Female | 0 | 0 | 0 | 1 (20.0) | 3 (23.1) | 1 (5.9) | 0 | 5 (11.9) | 0 | 0 | 0 |
| Race | |||||||||||
| White | 1 (100.0) | 1 (100.0) | 1 (100.0) | 4 (80.0) | 11 (84.6) | 14 (82.4) | 3 (75.0) | 35 (83.3) | 3 (75.0) | 2 (66.7) | 5 (71.4) |
| Black or African American | 0 | 0 | 0 | 1 (20.0) | 0 | 1 (5.9) | 0 | 2 (4.8) | 1 (25.0) | 1 (33.3) | 2 (28.6) |
| Asian | 0 | 0 | 0 | 0 | 0 | 2 (11.8) | 0 | 2 (4.8) | 0 | 0 | 0 |
| Not reported | 0 | 0 | 0 | 0 | 2 (15.4) | 0 | 1 (25.0) | 3 (7.1) | 0 | 0 | 0 |
| BMI (kg/m2), mean (SD) | 25.5 (—) | 28.4 (—) | 28.4 (—) | 27.7 (4.9) | 28.3 (6.3) | 29.5 (7.3) | 28.0 (2.1) | 28.6 (6.0) | 33.9 (10.1) | 26.4 (3.4) | 30.7 (8.4) |
| Primary diagnosis | |||||||||||
| Breast cancer | 0 | 0 | 0 | 0 | 1 (7.7) | 0 | 0 | 1 (2.4) | 0 | 0 | 0 |
| Colorectal cancer | 0 | 0 | 0 | 1 (20.0) | 2 (15.4) | 2 (11.8) | 0 | 5 (11.9) | 0 | 0 | 0 |
| Mesothelioma | 0 | 0 | 0 | 1 (20.0) | 0 | 0 | 0 | 1 (2.4) | 0 | 0 | 0 |
| Pancreatic carcinoma | 0 | 0 | 0 | 1 (20.0) | 1 (7.7) | 1 (5.9) | 0 | 3 (7.1) | 0 | 0 | 0 |
| Prostate cancer | 1 (100.0) | 1 (100.0) | 1 (100.0) | 1 (20.0) | 8 (61.5) | 14 (82.4) | 4 (100.0) | 30 (71.4) | 0 | 0 | 0 |
| Prostate cancer metastatic | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 (100.0) | 3 (100.0) | 7 (100.0) |
| Squamous cell carcinoma of head and neck | 0 | 0 | 0 | 1 (20.0) | 1 (7.7) | 0 | 0 | 2 (4.8) | 0 | 0 | 0 |
| Extent of disease | |||||||||||
| Locally advanced | 0 | 0 | 0 | 1 (20.0) | 0 | 0 | 0 | 1 (2.4) | 0 | 0 | 0 |
| Metastatic | 1 (100.0) | 1 (100.0) | 1 (100.0) | 4 (80.0) | 13 (100.0) | 17 (100.0) | 4 (100.0) | 41 (97.6) | 4 (100.0) | 3 (100.0) | 7 (100.0) |
| Prior anticancer treatment | |||||||||||
| ≥1 systemic therapy | |||||||||||
| Yes | 1 (100.0) | 1 (100.0) | 1 (100.0) | 5 (100.0) | 13 (100.0) | 17 (100.0) | 4 (100.0) | 42 (100.0) | 4 (100.0) | 3 (100.0) | 7 (100.0) |
| ≥1 radiotherapy | |||||||||||
| Yes | 1 (100.0) | 0 | 1 (100.0) | 3 (60.0) | 9 (69.2) | 11 (64.7) | 1 (25.0) | 26 (61.9) | 3 (75.0) | 2 (66.7) | 5 (71.4) |
| No | 0 | 1 (100.0) | 0 | 2 (40.0) | 4 (30.8) | 6 (35.3) | 3 (75.0) | 16 (38.1) | 1 (25.0) | 1 (33.3) | 2 (28.6) |
| ≥1 anticancer surgeries | |||||||||||
| Yes | 1 (100.0) | 0 | 1 (100.0) | 3 (60.0) | 13 (100.0) | 16 (94.1) | 4 (100.0) | 38 (90.5) | 4 (100.0) | 1 (33.3) | 5 (71.4) |
| No | 0 | 1 (100.0) | 0 | 2 (40.0) | 0 | 1 (5.9) | 0 | 4 (9.5) | 0 | 2 (66.7) | 2 (28.6) |
| Number of anticancer systemic therapy regimens | |||||||||||
| Missing | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1 | 0 | 1 (100.0) | 0 | 1 (20.0) | 0 | 0 | 0 | 2 (4.8) | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 | 1 (20.0) | 0 | 1 (5.9) | 1 (25.0) | 3 (7.1) | 0 | 0 | 0 |
| 3-5 | 0 | 0 | 0 | 1 (20.0) | 7 (53.8) | 8 (47.1) | 0 | 16 (38.1) | 2 (50.0) | 3 (100.0) | 5 (71.4) |
| ≥6 | 1 (100.0) | 0 | 1 (100.0) | 2 (40.0) | 6 (46.2) | 8 (47.1) | 3 (75.0) | 21 (50.0) | 2 (50.0) | 0 | 2 (28.6) |
| Median (range) | 6.0 (6-6) | 1.0 (1-1) | 10.0 (10-10) | 3.0 (1-10) | 5.0 (3-20) | 5.0 (2-9) | 6.0 (2-8) | 5.5 (1-20) | 5.5 (3-6) | 5.0 (3-5) | 5.0 (3-6) |
Values are presented as n (%) unless otherwise stated.
BMI, body mass index; Enza, enzalutamide; SD, standard deviation.