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

NCT01588522 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-05-28

Study results available
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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.

Conditions

  • Chemotherapy-Induced Alopecia

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

Sponsors & Collaborators

  • BPGbio

    lead INDUSTRY

Principal Investigators

  • Mario E Lacouture, MD · Memorial Sloan Kettering Cancer Center

  • Shari Goldfarb, MD · Memorial Sloan Kettering Cancer Center

  • Monica Mita, MD · Samuel Oschin Comprehensive Cancer Institute Cedars-Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-17
Primary Completion
2017-02-16
Completion
2017-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01588522 on ClinicalTrials.gov