Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia
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
Acronym
Not provided
Organization
BPGbioINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 17, 2012Actual
Primary Completion Date
Feb 16, 2017Actual
Completion Date
Feb 16, 2017Actual
First Submitted Date
Apr 20, 2012
First Submission Date that Met QC Criteria
Apr 27, 2012
First Posted Date
May 1, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 16, 2019
Results First Submitted that Met QC Criteria
May 22, 2025
Results First Posted Date
May 28, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 22, 2025
Last Update Posted Date
May 28, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BPGbioINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
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 Module
Conditions
Chemotherapy-Induced Alopecia
Keywords
alopecia
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
28Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Compound 31543 Calcitriol 5 μg/mL
Drug
5 μg/mL Topical Solution
Compound 31543 Calcitriol - 5 μg/mL
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Measure
Description
Time Frame
Pre-dose Concentrations of Compound 31543
Pre-dose concentrations of Compound 31543 from serum samples collected on Week 1 Day 1.
pre-dose on day 1 of Week 1
Cmax of Compound 31543 on Week 1 Day 1
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Samuel Oschin Comprehensive Cancer Institute Cedars-Sinai
Los Angeles
California
90048
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Patients scheduled to receive follow up treatment with a taxane-based chemotherapy regimen
Recruitment Details
Conducted at 2 US sites
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Compound 31543 Calcitriol - 5 μg/mL
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).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
All patients enrolled (signed the informed consent form).
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 2, 2015
Jun 12, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
A standard 3+3 dose escalation design was employed, over 6 dose levels, with 3 to 6 patients at each dose level.
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
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
Calcitriol
BPM31543 Topical Solution
Compound 31543 Calcitriol 10 μg/mL
Drug
10 μg/mL Topical Solution
Compound 31543 Calcitriol - 10 μg/mL
Calcitriol
BPM31543 Topical Solution
Compound 31543 Calcitriol 20 μg/mL
Drug
20 μg/mL Topical Solution
Compound 31543 Calcitriol - 20 μg/mL
Calcitriol
BPM31543 Topical Solution
Compound 31543 Calcitriol 40 μg/mL
Drug
40 μg/mL Topical Solution
Compound 31543 Calcitriol - 40 μg/mL
Calcitriol
BPM31543 Topical Solution
Compound 31543 Calcitriol 60 ug/mL
Drug
60 ug/mL Topical Solution
Compound 31543 Calcitriol - 60 μg/mL
Calcitriol
BPM31543 Topical Solution
Compound 31543 Calcitriol 80 μg/mL
Drug
80 μg/mL Topical Solution
Compound 31543 Calcitriol - 80 μg/mL
Calcitriol
BPM31543 Topical Solution
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.
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.
8 hours
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.
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.
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.
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.
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.
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.
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.
7 and 15 weeks
Memorial Sloan-Kettering Cancer Center
New York
New York
10022
United States
FG001
Compound 31543 Calcitriol - 10 μg/mL
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).
FG002
Compound 31543 Calcitriol - 20 μg/mL
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).
FG003
Compound 31543 Calcitriol - 40 μg/mL
Compound 31543 Calcitriol (40 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).
FG004
Compound 31543 Calcitriol - 60 μg/mL
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).
FG005
Compound 31543 Calcitriol - 80 μg/mL
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).
FG0003 subjects
FG0015 subjects
FG0026 subjects
FG0035 subjects
FG0046 subjects
FG0053 subjects
Treated
All patients who received at least one application of Compound 31543 Calcitriol.
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0034 subjects
FG0044 subjects
FG0053 subjects
COMPLETED
All patients that completed three 28 day cycles of Compound 31543 Calcitriol.
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0053 subjects
NOT COMPLETED
FG0002 subjects
FG0015 subjects
FG0024 subjects
FG0033 subjects
FG0044 subjects
FG0050 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0015 subjects
FG0023 subjects
FG0031 subjects
FG0042 subjects
FG0050 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Grade 2 alopecia
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Severe toxicity of chemotherapy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Taken off taxane-based regimen
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Did not initiate chemotherapy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety Population: Received at least 1 dose of Compound 31543 Calcitriol
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Compound 31543 Calcitriol - 5 ug/mL
Compound 31543 Calcitriol (5 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).
BG001
Compound 31543 Calcitriol - 10 ug/mL
Compound 31543 Calcitriol (10 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).
BG002
Compound 31543 Calcitriol - 20 ug/mL
Compound 31543 Calcitriol (20 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).
BG003
Compound 31543 Calcitriol - 40 ug/mL
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).
BG004
Compound 31543 Calcitriol - 60 ug/mL
Compound 31543 Calcitriol (60 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).
BG005
Compound 31543 Calcitriol - 80 ug/mL
Compound 31543 Calcitriol (80 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).
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0026
BG0034
BG0044
BG0053
BG00623
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00052.7± 8.5
BG00147.0± 6.08
BG00254.0± 12.98
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Consisted of all patients who received at least one application of Compound 31543.
Posted
Count of Participants
Participants
28 days
ID
Title
Description
OG000
Compound 31543 Calcitriol - 5 μg/mL
Compound 31543 Calcitriol, 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
OG001
Compound 31543 Calcitriol - 10 μg/mL
Compound 31543 Calcitriol, 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
OG002
Compound 31543 Calcitriol - 20 μg/mL
Compound 31543 Calcitriol, 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
OG003
Compound 31543 Calcitriol - 40 μg/mL
Compound 31543 Calcitriol, 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
OG004
Compound 31543 Calcitriol - 60 μg/mL
Compound 31543 Calcitriol, 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
OG005
Compound 31543 Calcitriol - 80 μg/mL
Compound 31543 Calcitriol, 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
Units
Counts
Participants
OG0003
OG0013
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Pre-dose Concentrations of Compound 31543
Pre-dose concentrations of Compound 31543 from serum samples collected on Week 1 Day 1.
Posted
Mean
Standard Deviation
pg/mL
pre-dose on day 1 of Week 1
ID
Title
Description
OG000
Compound 31543 Calcitriol - 5 ug/mL
Compound 31543 Calcitriol (5 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).
OG001
Compound 31543 Calcitriol - 10 ug/mL
Compound 31543 Calcitriol (10 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).
OG002
Compound 31543 Calcitriol - 20 ug/mL
Secondary
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.
Pharmacokinetic Parameters for Serum Calcitriol Concentrations on Week 1, Day 1 of BPM31543 Administration (PK Population)
The pharmacokinetic evaluable population was intended to include all patients with concentration results for the four samples scheduled for Week 1 Day 1.
Posted
Mean
Standard Deviation
pg/mL
8 hours
ID
Title
Description
OG000
5 μg/mL
BPM1543 Calcitriol, 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
OG001
10 μg/mL
BPM1543 Calcitriol, 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
OG002
20 μg/mL
BPM1543 Calcitriol, 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
Secondary
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.
Posted
Mean
Standard Deviation
pg•hour/mL
8 hours
ID
Title
Description
OG000
Compound 31543 Calcitriol - 5 ug/mL
Compound 31543 Calcitriol (5 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).
OG001
Compound 31543 Calcitriol - 10 ug/mL
Compound 31543 Calcitriol (10 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).
Secondary
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.
Evaluable Population defined as all patients who completed at least one photographic assessment and diary completion through Week 7. Some patients discontinued treatment prior to week 15 and are therefore only analyzed at week 7.
Posted
Mean
Standard Deviation
score on a scale
7 and 15 weeks
ID
Title
Description
OG000
5 μg/mL
BPM1543 Calcitriol, 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
OG001
10 μg/mL
BPM1543 Calcitriol, 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
OG002
20 μg/mL
BPM1543 Calcitriol, 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
Secondary
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.
Evaluable Population defined as all patients who completed at least one photographic assessment and diary completion through Week 7. Some patients discontinued treatment prior to week 15 and are therefore only analyzed at week 7.
Posted
Mean
Standard Deviation
score on a scale
7 and 15 weeks
ID
Title
Description
OG000
5 μg/mL
BPM1543 Calcitriol, 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
OG001
10 μg/mL
BPM1543 Calcitriol, 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
OG002
20 μg/mL
BPM1543 Calcitriol, 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
Secondary
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.
Evaluable Population defined as all patients who completed at least one photographic assessment and diary completion through Week 7. Some patients discontinued treatment prior to week 15 and are therefore only analyzed at week 7.
Posted
Mean
Standard Deviation
score on a scale
7 and 15 weeks
ID
Title
Description
OG000
5 μg/mL
BPM1543 Calcitriol, 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
OG001
10 μg/mL
BPM1543 Calcitriol, 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
OG002
20 μg/mL
BPM1543 Calcitriol, 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
Secondary
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.
Evaluable Population defined as all patients who completed at least one photographic assessment and diary completion through Week 7. Some patients discontinued treatment prior to week 15 and are therefore only analyzed at week 7.
Posted
Mean
Standard Deviation
score on a scale
7 and 15 weeks
ID
Title
Description
OG000
5 μg/mL
BPM1543 Calcitriol, 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
OG001
10 μg/mL
BPM1543 Calcitriol, 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
OG002
20 μg/mL
BPM1543 Calcitriol, 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
Secondary
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.
Evaluable Population defined as all patients who completed at least one photographic assessment and diary completion through Week 7. Some patients discontinued treatment prior to week 15 and are therefore only analyzed at week 7.
Posted
Mean
Standard Deviation
score on a scale
7 and 15 weeks
ID
Title
Description
OG000
5 μg/mL
BPM1543 Calcitriol, 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
OG001
10 μg/mL
BPM1543 Calcitriol, 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
OG002
20 μg/mL
BPM1543 Calcitriol, 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
Secondary
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.
Evaluable Population defined as all patients who completed at least one photographic assessment and diary completion through Week 7. Some patients discontinued treatment prior to week 15 and are therefore only analyzed at week 7.
Posted
Mean
Standard Deviation
score on a scale
7 and 15 weeks
ID
Title
Description
OG000
5 μg/mL
BPM1543 Calcitriol, 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
OG001
10 μg/mL
BPM1543 Calcitriol, 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
OG002
20 μg/mL
BPM1543 Calcitriol, 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
Secondary
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.
Evaluable Population defined as all patients who completed at least one photographic assessment and diary completion through Week 7. Not all patients had this photograph taken. Some patients discontinued treatment prior to week 15 and are therefore only analyzed at week 7.
Posted
Mean
Standard Deviation
score on a scale
7 and 15 weeks
ID
Title
Description
OG000
5 μg/mL
BPM1543 Calcitriol, 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
OG001
10 μg/mL
BPM1543 Calcitriol, 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
OG002
20 μg/mL
BPM1543 Calcitriol, 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
Time Frame
2 weeks (or 7 days ± 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 until termination of chemotherapy treatment (up to a maximum of 54 weeks)
Description
Safety assessments included treatment-emergent adverse events (TEAEs) and change from baseline (CFB) for vital signs (blood pressure, temperature, respiration rate, heart rate), physical examinations including weight, and laboratory tests (NCI-CTCAE v4.0) at Weeks 1, 2, 3, 5, 7, 11, 15, 27, and 54.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Compound 31543 Calcitriol - 5 μg/mL
BPM1543 Calcitriol, 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
0
3
0
3
3
3
EG001
Compound 31543 Calcitriol - 10 μg/mL
BPM1543 Calcitriol, 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
0
3
1
3
3
3
EG002
Compound 31543 Calcitriol - 20 μg/mL
BPM1543 Calcitriol, 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
0
6
1
6
6
6
EG003
Compound 31543 Calcitriol - 40 μg/mL
BPM1543 Calcitriol, 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
0
4
4
4
4
4
EG004
Compound 31543 Calcitriol - 60 μg/mL
BPM1543 Calcitriol, 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
0
4
1
4
3
4
EG005
Compound 31543 Calcitriol - 80 μg/mL
BPM1543 Calcitriol, 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
0
3
2
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Supraventicular Tachycardia
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pain
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Alkalosis
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Large Intestinal Obstruction
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dehyrdation
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Chest Pain
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vascular Pseudoaneurysm
Blood and lymphatic system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0003 events3 affected3 at risk
EG0013 events3 affected3 at risk
EG0020 events0 affected6 at risk
EG0032 events2 affected4 at risk
EG0043 events3 affected4 at risk
EG0053 events3 affected3 at risk
Rash Maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Pain of Skin
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Abdominal Pain
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Fatigue
General disorders
MedDRA (19.1)
Systematic Assessment
EG0003 events3 affected3 at risk
EG0012 events2 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Oedema Peripheral
General disorders
MedDRA (19.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pain
General disorders
MedDRA (19.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood Alkaline Phosphate Increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vitamin D Increased
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (19.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (19.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA (19.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
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.
Compound 31543 Calcitriol (20 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).
OG003
Compound 31543 Calcitriol - 40 ug/mL
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).
OG004
Compound 31543 Calcitriol - 60 ug/mL
Compound 31543 Calcitriol (60 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).
OG005
Compound 31543 Calcitriol - 80 ug/mL
Compound 31543 Calcitriol (80 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).
Units
Counts
Participants
OG0003
OG0013
OG0025
OG0032
OG0042
OG0053
Title
Denominators
Categories
Title
Measurements
OG00049.0± 5.8
OG00143.2± 14.8
OG00254.3± 31.5
OG00358.4± 19.4
OG00432.8± 5.2
OG00537.8± 15.5
OG003
40 μg/mL
BPM1543 Calcitriol, 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
OG004
60 μg/mL
BPM1543 Calcitriol, 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
OG005
80 μg/mL
BPM1543 Calcitriol, 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
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0032
OG0042
OG0052
Title
Denominators
Categories
Title
Measurements
OG00051.6± 6.9
OG00147.2± 13.6
OG00242.5± 8.5
OG00381.0± 8.1
OG00436.0± 9.8
OG00553.5± 16.1
OG002
Compound 31543 Calcitriol - 20 ug/mL
Compound 31543 Calcitriol (20 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).
OG003
Compound 31543 Calcitriol - 40 ug/mL
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).
OG004
Compound 31543 Calcitriol - 60 ug/mL
Compound 31543 Calcitriol (60 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).
OG005
Compound 31543 Calcitriol - 80 ug/mL
Compound 31543 Calcitriol (80 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).
Units
Counts
Participants
OG0003
OG0012
OG0023
OG0032
OG0042
OG0052
Title
Denominators
Categories
Title
Measurements
OG000346± 10
OG001334± 163
OG002259± 60
OG003530± 165
OG004230± 87
OG005370± 99
OG003
40 μg/mL
BPM1543 Calcitriol, 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
OG004
60 μg/mL
BPM1543 Calcitriol, 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
OG005
80 μg/mL
BPM1543 Calcitriol, 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
Units
Counts
Participants
OG0002
OG0012
OG0021
OG0032
OG0042
OG0053
Title
Denominators
Categories
Week 7
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0032
ParticipantsOG0042
ParticipantsOG0053
Title
Measurements
OG000-1± 0
OG001-1.5± 0.71
OG002-1
OG003
Week 15
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
OG003
40 μg/mL
BPM1543 Calcitriol, 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
OG004
60 μg/mL
BPM1543 Calcitriol, 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
OG005
80 μg/mL
BPM1543 Calcitriol, 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
Units
Counts
Participants
OG0002
OG0011
OG0022
OG0033
OG0042
OG0053
Title
Denominators
Categories
Week 7
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
Title
Measurements
OG000-1± 0
OG001-2
OG002-1± 0
OG003
Week 15
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
OG003
40 μg/mL
BPM1543 Calcitriol, 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
OG004
60 μg/mL
BPM1543 Calcitriol, 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
OG005
80 μg/mL
BPM1543 Calcitriol, 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
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0033
OG0042
OG0053
Title
Denominators
Categories
Week 7
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
Title
Measurements
OG000-0.5± 0.71
OG001-1± 0
OG002-1± 0
OG003
Week 15
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
OG003
40 μg/mL
BPM1543 Calcitriol, 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
OG004
60 μg/mL
BPM1543 Calcitriol, 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
OG005
80 μg/mL
BPM1543 Calcitriol, 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
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0033
OG0042
OG0053
Title
Denominators
Categories
Week 7
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
Title
Measurements
OG000-0.5± 0.71
OG001-0.5± 0.71
OG002-1± 0
OG003
Week 15
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
OG003
40 μg/mL
BPM1543 Calcitriol, 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
OG004
60 μg/mL
BPM1543 Calcitriol, 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
OG005
80 μg/mL
BPM1543 Calcitriol, 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
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0033
OG0042
OG0053
Title
Denominators
Categories
Week 7
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
Title
Measurements
OG000-0.5± 0.71
OG001-0.5± 0.71
OG002-1± 0
OG003
Week 15
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
OG003
40 μg/mL
BPM1543 Calcitriol, 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
OG004
60 μg/mL
BPM1543 Calcitriol, 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
OG005
80 μg/mL
BPM1543 Calcitriol, 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
Units
Counts
Participants
OG0001
OG0012
OG0022
OG0033
OG0042
OG0053
Title
Denominators
Categories
Week 7
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
Title
Measurements
OG000-1
OG001-1± 0
OG002-1± 0
OG003
Week 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
OG003
40 μg/mL
BPM1543 Calcitriol, 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
OG004
60 μg/mL
BPM1543 Calcitriol, 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
OG005
80 μg/mL
BPM1543 Calcitriol, 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