Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia
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.
Timeline
- Start
- 2012-09-17
- Primary completion
- 2017-02-16
- Completion
- 2017-02-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcitriol | Small molecule | 5 ug/ml | Topical |
| Subject | Calcitriol | Small molecule | 10 ug/ml | Topical |
| Subject | Calcitriol | Small molecule | 20 ug/ml | Topical |
| Subject | Calcitriol | Small molecule | 40 ug/ml | Topical |
| Subject | Calcitriol | Small molecule | 60 ug/ml | Topical |
| Subject | Calcitriol | Small molecule | 80 ug/ml | Topical |