CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
Compound 31543 Calcitriol 5 μg/mL +5 moredrug
Likely dose
Compound 31543 Calcitriol 5 μg/mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01588522
NCT01588522Phase 1Completed
CompareCT.gov

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

BPGbio·interventional·Posted May 1, 2012·Updated May 28, 2025

In Brief

A Phase 1 clinical trial evaluating Compound 31543 Calcitriol 5 μg/mL, Compound 31543 Calcitriol 10 μg/mL, and 4 other interventions for Chemotherapy-Induced Alopecia. Completed, enrolled 28 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChemotherapy-Induced Alopecia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 1, 2012
Enrollment StartSep 17, 2012
Primary CompletionFeb 16, 2017
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.2 years ago

Interventions

Compound 31543 Calcitriol 5 μg/mLdrug

5 μg/mL Topical Solution

Compound 31543 Calcitriol 10 μg/mLdrug

10 μg/mL Topical Solution

Compound 31543 Calcitriol 20 μg/mLdrug

20 μg/mL Topical Solution

Compound 31543 Calcitriol 40 μg/mLdrug

40 μg/mL Topical Solution

Compound 31543 Calcitriol 60 ug/mLdrug

60 ug/mL Topical Solution

Compound 31543 Calcitriol 80 μg/mLdrug

80 μg/mL Topical Solution