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Poster display session

4126 - A Phase I safety study of topical Calcitriol (BPM 31543) for the prevention of Chemotherapy-Induced Alopecia (CIA)

Date

10 Sep 2017

Session

Poster display session

Presenters

Brian Berman

Citation

Annals of Oncology (2017) 28 (suppl_5): v543-v567. 10.1093/annonc/mdx388

Authors

B. Berman1, J. Konner2, V.R. Belum2, H. Dion3, K. Ciccolini2, S. Kitts2, R. Ye3, S. Ravipaty3, V.R. Akmaev4, R. Sarangarajan4, J.J. Jimenez5, N. Narain4, S.B. Goldfarb2, M.E. Lacouture2

Author affiliations

  • 1 Dermatology, Center for Clinical and Cosmetic Research, 33136 - Miami/US
  • 2 Oncology, Memorial Sloan Kettering Cancer Center, 10065 - New York/US
  • 3 Biosystems, BERG, LLC, Framingham/US
  • 4 Biosystems, BERG, LLC, 01701 - Framingham/US
  • 5 Dermatology, University of Miami, 33136 - Miami/US
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Resources

Abstract 4126

Background

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.

Trial design

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

NCT01588522

Legal entity responsible for the study

BERG, LLC

Funding

BERG, LLC

Disclosure

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.

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