Chemotherapy-induced alopecia (CIA) may lead to significant psychosocial and quality of life issues. Currently there are no FDA approved therapeutic agents available to prevent CIA. In murine studies, topical calcitriol reduced CIA, likely due to arrest of cell cycle in healthy hair follicles and reducing sensitivity of follicular epithelium to chemotherapy.
A 3 + 3 dose-escalation Phase 1 study with 3 to 6 patients at each dose level (5/10/20/40/60/80 μg/mL) to determine the maximum tolerated dose (MTD) and the overall safety and tolerability of a topical compound BPM31543 (Calcitriol) in patients with a diagnosis of breast cancer, gynecologic cancer and sarcomas. Eligible patients receiving a taxane-based chemotherapy regimen applied 1mL of BPM31543 twice/daily at each cohort dose level 14 or 7 days prior to initiation of chemotherapy and then continued twice daily for 3 months or until termination of chemotherapy. In order to determine the MTD, dose escalation occurred in stepwise increments of the immediate prior dose group, in the absence of grade 3 or greater toxicities attributed to the topical calcitriol. Dose-limiting toxicity (DLT) was determined during Cycle 1 (i.e., the first 28 days of topical agent application). Patients were managed with adequate safety monitoring and pharmacokinetic (PK) analysis in order to determine levels of exposure. The potential efficacy (secondary objective) of the topical calcitriol was evaluated by photographic assessment using a Canon digital camera system (to ensure standardization and uniformity among all enrolled patients) in addition to patient self-assessments.
Clinical trial identification
Legal entity responsible for the study
B. Berman, J. Konner, V.R. Belum, K. Ciccolini, S. Kitts, J.J. Jimenez, S.B. Goldfarb, M.E. Lacouture: Clinical investigator paid by BERG, LLC to conduct studies. H. Dion. R. Ye, S. Ravipaty, V.R. Akmaev: Employee of BERG, LLC and has stock options. R. Sarangarajan, N. Narain: Employee of BERG, LLC and has stock options, also a co-founder of BERG, LLC.