Chemotherapy-Induced AlopeciaPhase 1NCT01588522
Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia
A Phase 1 study testing Compound 31543 Calcitriol 5 μg/mL, Compound 31543 Calcitriol 10 μg/mL and Compound 31543 Calcitriol 20 μg/mL in people with Chemotherapy-Induced Alopecia, run by BPGbio at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Alopecia
- What is being tested?
- Compound 31543 Calcitriol 5 μg/mL, Compound 31543 Calcitriol 10 μg/mL and Compound 31543 Calcitriol 20 μg/mL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Sep 2012to 16 Feb 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Samuel Oschin Comprehensive Cancer Institute Cedars-Sinai
Los Angeles, California, 90048
Memorial Sloan-Kettering Cancer Center
New York, New York, 10022
About this study
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
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?
Read more
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.
Read the detailed description
This was a multi-center, single arm, dose-escalation Phase 1 study to determine the maximum tolerated dose (MTD), PK, and the overall safety and tolerability of Compound 31543 in patients with a diagnosis of early-stage or locally advanced, unresectable and/or metastatic cancer, or patients with operable cancer, who were scheduled to receive follow up treatment with a taxane-based chemotherapy regimen, as per the physician's discretion. A standard 3+3 dose escalation design was employed, over 6 dose levels, with 3 to 6 patients at each dose level. Eligible patients in each cohort, >18 years of age and scheduled to receive a taxane-based regimen with treatment breaks as per physician's discretion, initially received or applied the topical formulation of Compound 31543 to the scalp twice daily 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).To determine the MTD for Compound 31543, dose escalation was conducted in stepwise increments, in the absence of dose-limiting toxicity (DLT) defined as clinically significant Grade 3 or 4 non-hematologic toxicity assessed as possibly, probably, or definitely related to Compound 31543 and not to the taxane-based chemotherapy, as best determined by investigator; assessment of DLTs was made weekly during the first 28 days of Compound 31543 treatment and subsequently thereafter every 4 weeks.
Pharmacokinetic (PK) data were evaluated for each dose level before escalation of Compound 31543 to the next dose level in all patients. PK blood samples were collected on Day 1 prior (pre-dose) to the first-morning dose of topical Compound 31543 and at 2, 4, and 8 hours post-dose after the first application of Compound 31543 on Day 1. PK samples were also collected 12 hours after the last, evening dose of Compound 31543 (i.e., before the first Day 1 of the next 28-day treatment) on Weeks 5, 9, 13, and 54.
Potential efficacy of the Compound 31543 was evaluated by photographic assessments and self-assessment diaries performed at baseline and Weeks 7, 15, 27, and 54. Photographic assessments were performed using a Canon digital camera system on views of the front of head/face, bilateral sides of head, and back and top of head/scalp view, as well as close-up photographs of a superior view and a vertex view with hair parted in the center and combed away from the part. Photographs were standardized for lighting, camera angle, and position to the participant's head.
Additionally, patients maintained a medication application diary and a self-assessment diary. The patient completed diary collected patient-reported assessments of hair thickness, fullness, volume, breakage, and cosmetic qualities (ease of styling, etc.) based on a 10-point analog scale for each parameter/question during the first 15 weeks after initiating calcitriol Compound 31543 and at Weeks 19, 23, and 27.
- Conditions
- Chemotherapy-Induced Alopecia
- Being tested
- 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
- Keywords
- alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound 31543 Calcitriol 5 μg/mLDrug
Also called Calcitriol, BPM31543 Topical Solution
5 μg/mL Topical Solution
Compound 31543 Calcitriol 10 μg/mLDrug
Also called Calcitriol, BPM31543 Topical Solution
10 μg/mL Topical Solution
Compound 31543 Calcitriol 20 μg/mLDrug
Also called Calcitriol, BPM31543 Topical Solution
20 μg/mL Topical Solution
Compound 31543 Calcitriol 40 μg/mLDrug
Also called Calcitriol, BPM31543 Topical Solution
40 μg/mL Topical Solution
Compound 31543 Calcitriol 60 ug/mLDrug
Also called Calcitriol, BPM31543 Topical Solution
60 ug/mL Topical Solution
Compound 31543 Calcitriol 80 μg/mLDrug
Also called Calcitriol, BPM31543 Topical Solution
80 μg/mL Topical Solution
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Drug: Compound 31543 Calcitriol 80 μg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (13)
Week 1 Day 1 Concentrations of Compound 31543
Concentrations of Compound 31543 from serum samples collected on Week 1 Day 1 pre-dose and at 2 ± 0.5 hours, 4 ± 0.5 hours, and 8 ± 1 hours post-dose.
Measured: At 0, 2, 4, and 8 h on Week 1 Day 1
Cmax of Compound 31543 on Week 1 Day 1
Cmax of Compound 31543 was calculated using serum samples collected on Week 1 Day 1 pre-dose and at 2 ± 0.5 hours, 4 ± 0.5 hours, and 8 ± 1 hours post-dose. The 8-hour Week 1 Day 1 sample was collected before the second of the daily doses.
Measured: 8 hours
AUC0-t of Compound 31543 on Week 1 Day 1
Area under the curve (AUC0-t) of Compound 31543 was calculated from serum samples collected on Week 1 Day 1 pre-dose and at 2 ± 0.5 hours, 4 ± 0.5 hours, and 8 ± 1 hours post-dose. The 8-hour Week 1 Day 1 sample was collected before the second of the daily doses.
Measured: 8 hours
Pre-Dose Concentrations of Compound 31543 at Week 5
Concentrations of Compound 31543 from serum samples collected pre-dose on Week 5 and >10 hours post previous dose.
Measured: Pre-dose Week 5
Pre-Dose Concentrations of Compound 31543 at Week 9
Concentrations of Compound 31543 from serum samples collected pre-dose on Week 9 and >10 hours post previous dose.
Measured: Pre-dose Week 9
Pre-Dose Concentrations of Compound 31543 at Week 13
Concentrations of Compound 31543 from serum samples collected pre-dose on Week 13 and >10 hours post previous dose.
Measured: Pre-dose Week 13
Top View Photographic Review Score
Top of head/scalp view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = >75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = >75% greatly increased/hair gain.
Measured: 7 and 15 weeks
Right Side Photographic Review Score
Right side of head/scalp view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = >75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = >75% greatly increased/hair gain.
Measured: 7 and 15 weeks
Left Side Photographic Review Score
Left side of head/scalp view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = >75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = >75% greatly increased/hair gain.
Measured: 7 and 15 weeks
Front Photographic Review Score
Front of head/face view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = >75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = >75% greatly increased/hair gain.
Measured: 7 and 15 weeks
Back Photographic Review Score
Back of head/face view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = >75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = >75% greatly increased/hair gain.
Measured: 7 and 15 weeks
Superior (Mid Pattern) Photographic Review Score
Mid-pattern of the scalp from a superior view at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = >75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = >75% greatly increased/hair gain.
Measured: 7 and 15 weeks
Vertex Photographic Review Score
Vertex view with hair parted in the center at 7 and 15 weeks were compared to baseline images and scored on a 7-point evaluation scale: -3 = >75% great hair loss; -2 = 50-75% moderate hair loss; -1 = 25-49% slight hair loss; 0 = 0-24% hair loss/gain, 1 = 25-49% slight hair gain; 2 = 50-75% moderate hair gain; 3 = >75% greatly increased/hair gain.
Measured: 7 and 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study start17 Sep 2012
- Primary completion16 Feb 2017
- Study completion16 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chemotherapy-Induced AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A standard 3+3 dose escalation design was employed, over 6 dose levels, with 3 to 6 patients at each dose level.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- BPGbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario E Lacouture, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterShari Goldfarb, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterMonica Mita, MD, Principal investigator, Samuel Oschin Comprehensive Cancer Institute Cedars-Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588522
- Sponsor's protocol ID
- CTL0211
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2012
- Last updated
- 17 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01588522
- Acronym / sponsor ID
- CTL0211
- Conditions
- Chemotherapy-Induced Alopecia
- Keywords
- alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BPGbioIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2012 (actual)
- Primary completion
- 16 Feb 2017 (actual)
- Study completion
- 16 Feb 2017 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Posted 28 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a multi-center, single arm, dose-escalation Phase 1 study to determine the maximum tolerated dose (MTD), PK, and the overall safety and tolerability of Compound 31543 in patients with a diagnosis of early-stage or locally advanced, unresectable and/or metastatic cancer, or patients with operable cancer, who were scheduled to receive follow up treatment with a taxane-based chemotherapy regimen, as per the physician's discretion. A standard 3+3 dose escalation design was employed, over 6 dose levels, with 3 to 6 patients at each dose level. Eligible patients in each cohort, >18 years of age and scheduled to receive a taxane-based regimen with treatment breaks as per physician's discretion, initially received or applied the topical formulation of Compound 31543 to the scalp twice daily 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).To determine the MTD for Compound 31543, dose escalation was conducted in stepwise increments, in the absence of dose-limiting toxicity (DLT) defined as clinically significant Grade 3 or 4 non-hematologic toxicity assessed as possibly, probably, or definitely related to Compound 31543 and not to the taxane-based chemotherapy, as best determined by investigator; assessment of DLTs was made weekly during the first 28 days of Compound 31543 treatment and subsequently thereafter every 4 weeks.
Pharmacokinetic (PK) data were evaluated for each dose level before escalation of Compound 31543 to the next dose level in all patients. PK blood samples were collected on Day 1 prior (pre-dose) to the first-morning dose of topical Compound 31543 and at 2, 4, and 8 hours post-dose after the first application of Compound 31543 on Day 1. PK samples were also collected 12 hours after the last, evening dose of Compound 31543 (i.e., before the first Day 1 of the next 28-day treatment) on Weeks 5, 9, 13, and 54.
Potential efficacy of the Compound 31543 was evaluated by photographic assessments and self-assessment diaries performed at baseline and Weeks 7, 15, 27, and 54. Photographic assessments were performed using a Canon digital camera system on views of the front of head/face, bilateral sides of head, and back and top of head/scalp view, as well as close-up photographs of a superior view and a vertex view with hair parted in the center and combed away from the part. Photographs were standardized for lighting, camera angle, and position to the participant's head.
Additionally, patients maintained a medication application diary and a self-assessment diary. The patient completed diary collected patient-reported assessments of hair thickness, fullness, volume, breakage, and cosmetic qualities (ease of styling, etc.) based on a 10-point analog scale for each parameter/question during the first 15 weeks after initiating calcitriol Compound 31543 and at Weeks 19, 23, and 27.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- A standard 3+3 dose escalation design was employed, over 6 dose levels, with 3 to 6 patients at each dose level.
| Arm | Type | Receives |
|---|---|---|
| Compound 31543 Calcitriol - 5 μg/mL | Experimental | Drug: Compound 31543 Calcitriol 5 μg/mLCompound 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). |
| Compound 31543 Calcitriol - 10 μg/mL | Experimental | Drug: Compound 31543 Calcitriol 10 μg/mLCompound 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). |
| Compound 31543 Calcitriol - 20 μg/mL | Experimental | Drug: Compound 31543 Calcitriol 20 μg/mLCompound 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). |
| Compound 31543 Calcitriol - 40 μg/mL | Experimental | Drug: Compound 31543 Calcitriol 40 μg/mLCompound 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). |
| Compound 31543 Calcitriol - 60 μg/mL | Experimental | Drug: Compound 31543 Calcitriol 60 ug/mLCompound 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). |
| Compound 31543 Calcitriol - 80 μg/mL | Experimental | Drug: Compound 31543 Calcitriol 80 μg/mLCompound 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound 31543 Calcitriol 5 μg/mLAlso: Calcitriol, BPM31543 Topical Solution5 μg/mL Topical Solution | Drug | Compound 31543 Calcitriol - 5 μg/mL |
| Compound 31543 Calcitriol 10 μg/mLAlso: Calcitriol, BPM31543 Topical Solution10 μg/mL Topical Solution | Drug | Compound 31543 Calcitriol - 10 μg/mL |
| Compound 31543 Calcitriol 20 μg/mLAlso: Calcitriol, BPM31543 Topical Solution20 μg/mL Topical Solution | Drug | Compound 31543 Calcitriol - 20 μg/mL |
| Compound 31543 Calcitriol 40 μg/mLAlso: Calcitriol, BPM31543 Topical Solution40 μg/mL Topical Solution | Drug | Compound 31543 Calcitriol - 40 μg/mL |
| Compound 31543 Calcitriol 60 ug/mLAlso: Calcitriol, BPM31543 Topical Solution60 ug/mL Topical Solution | Drug | Compound 31543 Calcitriol - 60 μg/mL |
| Compound 31543 Calcitriol 80 μg/mLAlso: Calcitriol, BPM31543 Topical Solution80 μg/mL Topical Solution | Drug | Compound 31543 Calcitriol - 80 μg/mL |
Primary outcome
Dose-limiting Toxicities (DLT) of Topical Compound 31543
Time frame: 28 days
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.
13 secondary outcomes
Week 1 Day 1 Concentrations of Compound 31543
Time frame: At 0, 2, 4, and 8 h on Week 1 Day 1
Cmax of Compound 31543 on Week 1 Day 1
Time frame: 8 hours
AUC0-t of Compound 31543 on Week 1 Day 1
Time frame: 8 hours
Pre-Dose Concentrations of Compound 31543 at Week 5
Time frame: Pre-dose Week 5
Pre-Dose Concentrations of Compound 31543 at Week 9
Time frame: Pre-dose Week 9
Pre-Dose Concentrations of Compound 31543 at Week 13
Time frame: Pre-dose Week 13
Top View Photographic Review Score
Time frame: 7 and 15 weeks
Right Side Photographic Review Score
Time frame: 7 and 15 weeks
Left Side Photographic Review Score
Time frame: 7 and 15 weeks
Front Photographic Review Score
Time frame: 7 and 15 weeks
Back Photographic Review Score
Time frame: 7 and 15 weeks
Superior (Mid Pattern) Photographic Review Score
Time frame: 7 and 15 weeks
Vertex Photographic Review Score
Time frame: 7 and 15 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario E Lacouture, MD principal investigator
Memorial Sloan Kettering Cancer Center
Shari Goldfarb, MD principal investigator
Memorial Sloan Kettering Cancer Center
Monica Mita, MD principal investigator
Samuel Oschin Comprehensive Cancer Institute Cedars-Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Compound 31543 Calcitriol 5 μg/mL, Compound 31543 Calcitriol 10 μg/mL and Compound 31543 Calcitriol 20 μg/mL in people with Chemotherapy-Induced Alopecia, run by BPGbio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicities (DLT) of Topical Compound 31543 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.