A Phase I Safety Study of Topical Calcitriol (BPM31543) for the Prevention of Chemotherapy-Induced Alopecia: Final Study Results

In a Phase 1 safety study from October 2018, topical calcitriol (BPM31543) was tested on 23 patients with breast cancer, gynecologic cancer, or sarcomas undergoing taxane-based chemotherapy to prevent chemotherapy-induced alopecia (CIA). Patients applied the treatment twice daily at escalating doses ranging from 5 to 80 µg/mL. The study found that BPM31543 was safe and well-tolerated, with no maximum tolerated dose (MTD) reached and no dose-limiting toxicity (DLT) observed. The most common treatment emergent adverse events (TEAEs) were fatigue, nausea, and peripheral sensory neuropathy, which were attributed to chemotherapy, while elevated vitamin D and rash were possibly related to the treatment. At week 7, 8 patients experienced less than 50% hair loss, and by week 15, 2 patients maintained this level of hair preservation. No significant changes in serum levels of calcitriol were detected. The results suggest some efficacy and support further research in Phase 2/3 trials. The study was funded and conducted by BERG, LLC, with several authors having affiliations with the company.