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Dosing Schema and DLT Summary
| Dose level | Pasireotide SC BID (days 1–42) | Pasireotide LAR IM (day 29 and every 4 wks thereafter) | Everolimus (po qd) | N (21 evaluable) | DLT |
|---|---|---|---|---|---|
| 1 | 600 mcg | 40 mg | 5 mg | 3 | None |
| 2 | 900 mcg | 60 mg | 5 mg | 3 | None |
| 3 | 900 mcg | 60 mg | 10 mg | 6 +6 (expansion cohort) |
Grade 3 rash (n=1) |
| 4 | 1200 mcg | 80 mg* | 10 mg | 3 | Grade 3 diarrhea (n=1). |
Dose level 4 was discontinued. Patients transitioned to dose level 3 prior to administration of pasireotide LAR 80mg.
