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Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia
Sponsor: BPGbio
Summary
The goal of this clinical trial is to learn if Compound 31543 (topical calcitriol) for treatment of hair-loss in patients with a diagnosis of breast cancer, gynecologic cancer or sarcomas receiving a taxane-based chemotherapy is safe. The main questions it aims to answer are: * What medical problems do participants have when using compound 31543? * How much Compound 31543 is in blood after treatment? * How much hair is lost during treatment? Participants will: * Apply Compound 31543 to their scalp twice a day, starting at least 5 days before starting chemotherapy for at least 3 months or until chemotherapy treatment is completed. * Have blood drawn on weeks 1, 5, 9, 13, and 54. * Have photographs taken of their hair before starting and at weeks 7, 15, 27, and 54. * Keep a diary of the condition of their hair.
Official title: Phase I Dose-Escalation Study, to Evaluate the Safety, Tolerability and Pharmacokinetics of a Topical Compound 31543 (Calcitriol, USP) in Adult Cancer Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Advanced or Recurrent Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2012-09-17
Completion Date
2017-02-16
Last Updated
2026-08-17
Healthy Volunteers
No
Conditions
Interventions
Compound 31543 Calcitriol 5 μg/mL
5 μg/mL Topical Solution
Compound 31543 Calcitriol 10 μg/mL
10 μg/mL Topical Solution
Compound 31543 Calcitriol 20 μg/mL
20 μg/mL Topical Solution
Compound 31543 Calcitriol 40 μg/mL
40 μg/mL Topical Solution
Compound 31543 Calcitriol 60 ug/mL
60 ug/mL Topical Solution
Compound 31543 Calcitriol 80 μg/mL
80 μg/mL Topical Solution
Locations (2)
Samuel Oschin Comprehensive Cancer Institute Cedars-Sinai
Los Angeles, California, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States