Table 1 Patient characteristics

From: A phase 1 dose-escalation and expansion study of binimetinib (MEK162), a potent and selective oral MEK1/2 inhibitor

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)

  1. Abbreviations: BID=twice daily; ECOG=Eastern Cooperative Oncology Group; MTD=maximum tolerated dose.
  2. aIncludes appendiceal, carcinoma of unknown primary, eccrine adenocarcinoma, gastric, melanoma, nerve sheath tumour, and parotid.
  3. bPatients may have received more than 1 prior cancer treatment.
  4. cAfter 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.
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