Phase 1Completed
Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia
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
- Sponsor
- BPGbio (Industry)
- Enrolment
- 28 enrolled
- Conditions
- Chemotherapy-Induced Alopecia
- Interventions
- Compound 31543 Calcitriol 5 μg/mL; Compound 31543 Calcitriol 10 μg/mL; Compound 31543 Calcitriol 20 μg/mL; Compound 31543 Calcitriol 40 μg/mL; Compound 31543 Calcitriol 60 ug/mL; Compound 31543 Calcitriol 80 μg/mL
- Ages
- adults, older adults
- Registry
- NCT01588522
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Dose-limiting Toxicities (DLT) of Topical Compound 31543
History
Last registry update
Results first posted
Primary completion
Started
Registered