Leong S, et al. – Safety and pharmacokinetics of pictilisib in combination with erlotinib in patients with advanced solid tumors had been assessed. This combination was found to be feasible. However, it had limited antitumor activity.

Methods

• At a starting daily dose of 60 mg pictilisib on days 1–21 of a 28-day cycle and 150 mg erlotinib from day 2 of cycle 1, a 3+3 dose-escalation study was carried out.
• To assess safety and tolerability, identify dose-limiting toxicities (DLTs), estimate the maximum tolerated dose, and identify the recommended phase II dose (RP2D) were the primary objectives of the study.
• Researchers assessed a dose-expansion cohort at the RP2D.

Results

• This study provided treatment to fifty-seven patients.
• They noticed at least one adverse event (AE) in all patients.
• They reported Grade ≥3 AEs, serious AEs, and deaths in 38 (66.7%), 19 (33.3%), and 4 (7.0%) patients, respectively.
• Nine patients across eight cohorts experienced DLTs.
• In addition, the RP2D was determined to be 340 mg pictilisib on a “5 days on, 2 days off” schedule plus 100 mg erlotinib.
• Partial response was occurred in two patients (3.5%), and stable disease was observed in 19 (33.3%).