A randomized, open-label, two-way crossover clinical trial to evaluate the food effect on pharmacokinetics and safety of DHP107 in patients with advanced solid tumors: the FEEL study.

PURPOSE: The phase 1, randomized, open-label, two-way crossover FEEL study assessed the effect of food on the pharmacokinetics of DHP107, an oral paclitaxel with a novel lipid formulation designed to be systemically absorbed without Cremophor EL, in patients with advanced solid tumors.

METHODS

Patients were randomized 1:1 to DHP107 (200 mg/m2 orally twice daily on Days 1, 8, 15 every 28 days for two cycles) treatment sequences: fasted-fed (first DHP107 dose administered after overnight fast; n = 13) and fed-fasted (first DHP107 dose administered after a high-fat meal; n = 12). The primary objective was to evaluate the effect of food on DHP107 pharmacokinetics. The secondary objective was DHP107 safety; efficacy was also assessed (both in all patients regardless of dosing sequence).

RESULTS

Mean systemic exposures were similar for paclitaxel and its metabolites under fed and fasted conditions. Geometric mean ratios (fed:fasted) for paclitaxel were: maximum concentration (Cmax), 101.00% (95% CI 91.93-110.95%); area under the curve (AUC0-72), 102.92% (95% CI 95.04-111.45%); and AUC0-inf 104.76% (95% CI 96.44-113.80%), meeting criteria for no food effect. Common adverse events across the study period included diarrhea (fasted-fed 61.5%; fed-fasted 41.7%), vomiting (fasted-fed 30.8%; fed-fasted 8.3%), and neutropenia (fasted-fed 23.1%; fed-fasted 16.7%). Two fed-fasted patients (16.7%) had partial responses and six had stable disease (50.0%); seven fasted-fed patients had stable disease (53.8%).

CONCLUSION

This study suggests that the pharmacokinetics of DHP107 are unaffected by food and DHP107 can be taken with or without food.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04675528; 107CS-7.