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COMPLETED
NCT01588522
PHASE1

Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia

Sponsor: BPGbio

View on ClinicalTrials.gov

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

Interventions

DRUG

Compound 31543 Calcitriol 5 μg/mL

5 μg/mL Topical Solution

DRUG

Compound 31543 Calcitriol 10 μg/mL

10 μg/mL Topical Solution

DRUG

Compound 31543 Calcitriol 20 μg/mL

20 μg/mL Topical Solution

DRUG

Compound 31543 Calcitriol 40 μg/mL

40 μg/mL Topical Solution

DRUG

Compound 31543 Calcitriol 60 ug/mL

60 ug/mL Topical Solution

DRUG

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