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

NCT01588522 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CTL0211
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

alopecia

Outcome Measures

Primary Outcomes (1)

• Dose-limiting Toxicities (DLT) of Topical Compound 31543

  DLTs were graded according to the CTCAE v4.0. A DLT was defined as a clinically significant Grade 3 or 4 (severe or life-threatening, respectively) non-hematologic toxicity occurring during the first 28-day treatment cycle, and determined to be possibly, probably, or definitely related to BPM31543 and not the taxane-based regimen as best determined by investigators.

  28 days

Secondary Outcomes (10)

• Pre-dose Concentrations of Compound 31543

  pre-dose on day 1 of Week 1

• Cmax of Compound 31543 on Week 1 Day 1

  8 hours

• AUC0-t of Compound 31543 on Week 1 Day 1

  8 hours

• Top View Photographic Review Score

  7 and 15 weeks

• Right Side Photographic Review Score

  7 and 15 weeks

Study Arms (6)

Compound 31543 Calcitriol - 5 μg/mL

EXPERIMENTAL

Compound 31543 Calcitriol (5 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).

Drug: Compound 31543 Calcitriol 5 μg/mL

Compound 31543 Calcitriol - 10 μg/mL

EXPERIMENTAL

Compound 31543 Calcitriol (10 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).

Drug: Compound 31543 Calcitriol 10 μg/mL

Compound 31543 Calcitriol - 20 μg/mL

EXPERIMENTAL

Compound 31543 Calcitriol (20 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).

Drug: Compound 31543 Calcitriol 20 μg/mL

Compound 31543 Calcitriol - 40 μg/mL

EXPERIMENTAL

Compound 31543 Calcitriol (40 ug/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).

Drug: Compound 31543 Calcitriol 40 μg/mL

Compound 31543 Calcitriol - 60 μg/mL

EXPERIMENTAL

Compound 31543 Calcitriol (60 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).

Drug: Compound 31543 Calcitriol 60 ug/mL

Compound 31543 Calcitriol - 80 μg/mL

EXPERIMENTAL

Compound 31543 Calcitriol (80 μg/mL), Topical application, 0.25 mL to be applied to each of the four quadrants of the scalp twice daily, morning and night with 10-14 hours between applications either for 2 weeks or 7 ± 2 days (if the patient was unable or unwilling to undergo 2 weeks of pre-treatment) prior to the first dose of chemotherapy and continued the application twice daily for the duration of the individual patient's chemotherapy (up to a maximum of 54 weeks).

Drug: Compound 31543 Calcitriol 80 μg/mL

Interventions

Compound 31543 Calcitriol 5 μg/mL DRUG

5 μg/mL Topical Solution

Also known as: Calcitriol, BPM31543 Topical Solution

Compound 31543 Calcitriol - 5 μg/mL

Compound 31543 Calcitriol 10 μg/mL DRUG

10 μg/mL Topical Solution

Also known as: Calcitriol, BPM31543 Topical Solution

Compound 31543 Calcitriol - 10 μg/mL

Compound 31543 Calcitriol 20 μg/mL DRUG

20 μg/mL Topical Solution

Also known as: Calcitriol, BPM31543 Topical Solution

Compound 31543 Calcitriol - 20 μg/mL

Compound 31543 Calcitriol 40 μg/mL DRUG

40 μg/mL Topical Solution

Also known as: Calcitriol, BPM31543 Topical Solution

Compound 31543 Calcitriol - 40 μg/mL

Compound 31543 Calcitriol 60 ug/mL DRUG

60 ug/mL Topical Solution

Also known as: Calcitriol, BPM31543 Topical Solution

Compound 31543 Calcitriol - 60 μg/mL

Compound 31543 Calcitriol 80 μg/mL DRUG

80 μg/mL Topical Solution

Also known as: Calcitriol, BPM31543 Topical Solution

Compound 31543 Calcitriol - 80 μg/mL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients at least 18 years of age
• Able to fully understand and participate in the informed consent process
• Patients who are scheduled to receive a taxane-based regimen for a histologically confirmed solid tumor that is:
• Early stage and/or treatment naïve, or
• Relapsed or is refractory to previous therapy, or
• Operable and necessitates adjuvant or neo-adjuvant treatment
• Have no evidence of alopecia or mild alopecia (NCI CTCAE v.4.0 grade 1 alopecia defined as hair loss of \<50% of normal for that individual that is not obvious from a distance but only on close inspection; a different hair style may be required to cover the hair loss but it does not require a wig or hair piece to camouflage). Female/male-pattern baldness or age-related hair loss are allowed if not greater than grade 1, per NCI-CTCAE v. 4.0. Patients that have previously lost their hair may enroll if they currently have Grade 0 or 1 alopecia
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 within 14 days prior to registration
• Has baseline neutrophil counts of \> 1500 cells/mm3 within 72 hours prior to registration
• Has serum calcium less than or equal to upper limit of normal (ULN) (for patients with an albumin lower than 3.0, a corrected calcium serum calcium = serum calcium +\[0.8\]\[3.5-serum albumin\]) within 72 hours prior to registration

You may not qualify if:

• Patients receiving calcium-lowering therapy or drugs that may affect calcium levels (e.g., calcitonin, mithramycin, phosphate, denosumab) within 4 weeks of initiation of topical calcitriol. Patients who have been managed with bisphosphonates or calcium-lowering therapy for 3 months or greater prior to the start of the trial and have demonstrated evidence for stability of calcium metabolism would be considered eligible for participation in the trial.
• Has a history of drug or alcohol abuse within 1 year of study enrollment as determined by the investigator.
• Patients who elect to shave the scalp hair prior to the initiation of chemotherapy or who plan to do so during the chemotherapy treatment.
• Any dermatological condition that in the opinion of the investigator will affect the absorption of the study medication, e.g. Atopic Dermatitis, etc.
• Has been treated with an investigational agent within 30 days or six half-lives of its biologic activity whichever is longer, before the start of study. (Patients may not be concurrently enrolled on another trial or concurrently treated with another investigational agent)
• Patients with a history of hypercalcemia or vitamin D toxicity, or hospitalization for treatment of angina, myocardial infarction, or congestive heart failure or psychiatric illness currently or within 30 days of study entry as determined by the investigator.
• Has a history of significant allergy to calcitriol as determined by the investigator.
• Has any condition that interferes with the ability of the subject to understand or comply with the requirements of the study.
• Patients taking Vitamin D supplements during the study, unless they have been taking Vitamin D supplements for 30 days or more prior to the start of the study and that the dose of the Vitamin D supplement remain the same throughout the study.
• Patients treated with medications that are known to affect calcium levels within 4 weeks of initiation of topical therapy (\>500 IU vitamin A, calcium supplements, fluoride, antiepileptics).with the exception of patients on stable therapy for more than six months
• Patients with hypercalcemia or kidney stones
• Patients that indicate they have significant hair breakage or hair damage and associated hair loss from hair over-processing within the last 30 days due to peroxide applications, permanent hair coloring, bleaches, streaking, perms, relaxers and/or hair oxidative dyes.
• Current alopecia grade 2 or greater as per NCI-CTCAE v.4.0, or significant hair loss or hair breakage
• Prior radiation to the cranium
• Pregnant or breastfeeding

Sponsors & Collaborators

• BPGbio: lead

Study Sites (2)

Samuel Oschin Comprehensive Cancer Institute Cedars-Sinai

Los Angeles, California, 90048, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

The tables in this report reflect safety and effectiveness data to the best knowledge of the sponsor. However, the results were generated from partially audited data.

Results Point of Contact

• Title: Bing Nie
• Organization: BPGbio Inc.

bing.nie@bpgbio.com

617-588-1002

Study Officials

• Mario E Lacouture, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Shari Goldfarb, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Monica Mita, MD

  Samuel Oschin Comprehensive Cancer Institute Cedars-Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A standard 3+3 dose escalation design was employed, over 6 dose levels, with 3 to 6 patients at each dose level.

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: May 1, 2012
• Study Start: September 17, 2012
• Primary Completion: February 16, 2017
• Study Completion: February 16, 2017
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Locations

US (2)