Table 1 Dose-escalation schema of combination selumetinib and cixutumumab

From: A phase I trial of vertical inhibition of IGF signalling using cixutumumab, an anti-IGF-1R antibody, and selumetinib, an MEK 1/2 inhibitor, in advanced solid tumours

Dose level

Selumetinib

Cixutumumab

Number enrolled

Number evaluable a

DLT (Y/N)

−1

50 mg orally twice daily

6 mg kg−1 IV every 2 weeks

0

0

n/a

1 (starting dose)

50 mg orally twice daily

12 mg kg−1 IV every 2 weeks

6

6

One patient

Black dots in visual field, no abnormalities on exam

2

75 mg orally twice daily

12 mg kg−1 IV every 2 weeks

10

7

Two patients

Scotoma and flashes, no findings on exam

Blind spots/decreased visual acuity

  1. Abbreviations: DLT= dose-limiting toxicity; N= no; Y= yes.
  2. aRefers to the number of patients receiving at least 4 weeks of study drugs, and included in calculations for target dose-limiting toxicity of ⩽20% patients. The remaining patients did not receive an entire cycle of treatment and were not included.
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