Trial profile.
fatigue
Flow chart for enrollment indicating patient course for phase 1 and phase 2.Baseline characteristics of the intention-to-treat population.In Phase 1 dose escalation, three patients were treated at dose level 1 and eight patients at dose level 2. All patients at dose level 1 were evaluable for DLT and there were no DLTs observed. At dose level 2, there were two patients that were not evaluable for DLT based on insufficient olaparib dosing in the 28-day DLT period. Of the six evaluable patients treated at dose level 2, there was one DLT for grade 3 fatigue. Thus, dose level 2 of olaparib 300 mg twice daily with ramucirumab 8 mg/kg on day 1 every 14 days was determined to be the RP2D. The study then proceeded to dose expansion, where 40 additional patients were treated with olaparib 300 mg twice daily with ramucirumab 8 mg/kg on day 1 every 14 days.In the intention-to-treat (ITT) population treated at the RP2D there were 6 PRs observed in 43 evaluable patients by RECIST with an ORR of 6/43 (14%) (95% CI 4.7–25.6) (Fig. 