Topical calcitriol (BPM31543) for the prevention of chemotherapy-induced alopecia (CIA): Efficacy findings from a phase I safety study.

2564Background: Cancer patients receiving taxane-based chemotherapy develop alopecia, which may lead to significant psychosocial, quality of life, and adherence issues. Besides a recently FDA-cleared scalp cooling device, there are no oral/ topical agents available prevent CIA. In murine studies, topical calcitriol reduced CIA, likely due to arrest of cell cycle in healthy hair follicles, and reduction in the sensitivity of follicular epithelium to chemotherapy. Methods: Up to 31 adult women with cancer (breast, gynecologic, soft-tissue/bone sarcoma) applied 1mL of BPM31543 to scalp bid, ≥ 5 days prior to initiation of taxane-based chemotherapy until 3 months or end of chemotherapy, in this dose-escalation study (5/10/20/40/60/80μg/mL cohorts). Periodic PK analysis, adverse event (AE) monitoring, patient self-assessment diaries (1-10 scale), and blinded photographic assessments were done. Results: Twenty-one subjects have been enrolled so far (evaluable, n = 13). PK data (n = 16; 5-40μg/mL) showed inter-i...