A Randomized, Placebo-controlled, Parallel Phase 2a Dose-ranging Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated with Epidermal Growth Factor Receptor Inhibitors CLEER Trial (Chemotherapy Longevity by Evading EGFR Inhibitor Reactions)

Skin Toxicities Associated with Epidermal Growth Factor Receptor Inhibitors

Part 1 (open-label PK cohort) • Investigating PK parameters including: measured drug concentrations above the lower limit of quantitation, number of participants with measurable systemic exposure; if data allow - area under the curve (AUC), maximum (or peak) concentration (Cmax), and time of peak concentration (Tmax), Part 2 (randomized double-blind cohort) • Proportion of participants with a grade ≤ 1 based on the ARIGA scale after 6 weeks of HT-001 treatment

• Change from Baseline in pruritus numeric rating scale (NRS; average itch and worst itch) after 3 weeks and 6 weeks of HT-001 treatment compared to placebo, • Change from Baseline in pain based on an NRS after 3 weeks and 6 weeks of HT-001 treatment compared to placebo, • Change from Baseline in acneiform rash grade based on the ARIGA scale at 3 weeks and 6 weeks of HT-001 treatment compared to placebo, • Time to improvement for at least 1 grade using the ARIGA scale for acneiform rash for HT-001 treatment compared to placebo, • Time to topical rescue therapy treatment after initiation of HT-001 treatment compared to placebo, • Proportion of patients with EGFRI dose reduction or discontinuation due to EGFR inhibitor skin toxicities after 6 weeks of HT-001 treatment compared to placebo, • Safety and tolerability of HT-001 as measured by: o Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs), • Safety and tolerability of HT-001 as measured by: o Skin irritation, as assessed using the modified Draize Scale to evaluate cutaneous signs of erythema and edema, • Safety and tolerability of HT-001 as measured by: o Physical examinations, • Safety and tolerability of HT-001 as measured by: o Vital signs, • Safety and tolerability of HT-001 as measured by: o 12-lead electrocardiograms (ECG), • Safety and tolerability of HT-001 as measured by: o Clinical laboratory values (hematology, chemistry, urinalysis), including transaminase and bilirubin levels

No related papers found yet.

Hungary, Poland, Spain