Table 1. Patient characteristics.
| Characteristic | N=93 |
|---|---|
| Median age, years (range) | 58 (30–86) |
|
Sex, n (%) | |
| Men | 57 (61) |
| Women | 36 (39) |
|
Race, n (%) | |
| White | 80 (86) |
| Black/African American | 7 (8) |
| Asian | 3 (3) |
| Other | 3 (3) |
|
Tumour type, n (%) | |
| Colorectal | 53 (57) |
| Biliary | 30 (32) |
| Pancreas | 3 (3) |
| Othera | 7 (8) |
|
ECOG performance status, n (%) | |
| 0 | 50 (54) |
| 1 | 42 (45) |
| 2 | 1 (1) |
| Median prior regimens for advanced/metastatic disease (range) | 2 (0–10) |
|
Prior treatments,b
n (%) | |
| Radiation | 30 (32) |
| Surgery | 73 (78) |
| Adjuvant therapy | 48 (52) |
|
Enrolment, n (%) | |
| Dose-escalation phase | 19 (20) |
| 30 mg BID | 4 (4) |
| 45 mg BID | 4 (4) |
| 60 mg BID | 7 (8) |
| 80 mg BID | 4 (4) |
| Expansion phasec | 74 (80) |
| Biliary cancer cohort (60 mg BID) | 28 (30) |
| KRAS-mutant colorectal cancer cohort (60 mg BID) | 6 (6) |
| KRAS-mutant colorectal cancer cohort (45 mg BID) | 25 (27) |
| BRAF-mutant colorectal cancer cohort (45 mg BID) | 15 (16) |
Abbreviations: BID=twice daily; ECOG=Eastern Cooperative Oncology Group; MTD=maximum tolerated dose.
a
Includes appendiceal, carcinoma of unknown primary, eccrine adenocarcinoma, gastric, melanoma, nerve sheath tumour, and parotid.
b
Patients may have received more than 1 prior cancer treatment.
c
After initiating the expansion phase, a higher-than-expected incidence of ocular AEs affected the ability to treat patients continuously at the MTD of 60 mg BID. The dose was therefore reduced to 45 mg BID for the remainder of newly enroled expansion phase patients.