Trial · NCT01588522
Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia
NCT01588522, Phase 1, Completed, BPGbio; results first posted 2025-05-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia. Trials, record NCT01588522. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01588522
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia
- NCT number
- NCT01588522
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 28 participants, actual
- Lead sponsor
- BPGbio
- Conditions
- Chemotherapy-Induced Alopecia
- Interventions
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, Compound 31543 Calcitriol 80 μg/mL
- First posted
- 2012-05-01
- Last updated
- 2026-08-17
- Results first posted
- 2025-05-28
- Limitations and caveats
- The tables in this report reflect safety and effectiveness data to the best knowledge of the sponsor.~However, the results were generated from partially audited data.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting Toxicities (DLT) of Topical Compound 31543 | 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. |
| Secondary | Week 1 Day 1 Concentrations of Compound 31543 | At 0, 2, 4, and 8 h on Week 1 Day 1 | 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. |
| Secondary | Cmax of Compound 31543 on Week 1 Day 1 | 8 hours | 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. |
| Secondary | AUC0-t of Compound 31543 on Week 1 Day 1 | 8 hours | 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. |
| Secondary | Pre-Dose Concentrations of Compound 31543 at Week 5 | Pre-dose Week 5 | Concentrations of Compound 31543 from serum samples collected pre-dose on Week 5 and \>10 hours post previous dose. |
| Secondary | Pre-Dose Concentrations of Compound 31543 at Week 9 | Pre-dose Week 9 | Concentrations of Compound 31543 from serum samples collected pre-dose on Week 9 and \>10 hours post previous dose. |
| Secondary | Pre-Dose Concentrations of Compound 31543 at Week 13 | Pre-dose Week 13 | Concentrations of Compound 31543 from serum samples collected pre-dose on Week 13 and \>10 hours post previous dose. |
| Secondary | Top View Photographic Review Score | 7 and 15 weeks | 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. |
| Secondary | Right Side Photographic Review Score | 7 and 15 weeks | 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. |
| Secondary | Left Side Photographic Review Score | 7 and 15 weeks | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-limiting Toxicities (DLT) of Topical Compound 31543 | 28 days | Consisted of all patients who received at least one application of Compound 31543. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pre-dose Concentrations of Compound 31543 | pre-dose on day 1 of Week 1 | pg/mL | MEAN | |
| SECONDARY | Cmax of Compound 31543 on Week 1 Day 1 | 8 hours | 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. | pg/mL | MEAN |
| SECONDARY | AUC0-t of Compound 31543 on Week 1 Day 1 | 8 hours | pg•hour/mL | MEAN | |
| SECONDARY | Top View Photographic Review Score | 7 and 15 weeks | 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. | score on a scale | MEAN |
| SECONDARY | Right Side Photographic Review Score | 7 and 15 weeks | 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. | score on a scale | MEAN |
| SECONDARY | Left Side Photographic Review Score | 7 and 15 weeks | 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. | score on a scale | MEAN |
| SECONDARY | Front Photographic Review Score | 7 and 15 weeks | 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. | score on a scale | MEAN |
| SECONDARY | Back Photographic Review Score | 7 and 15 weeks | 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. | score on a scale | MEAN |
| SECONDARY | Superior (Mid Pattern) Photographic Review Score | 7 and 15 weeks | 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. | score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group97
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose-limiting Toxicities (DLT) of Topical Compound 31543 | Compound 31543 Calcitriol - 5 μg/mL | 0 | Participants | ||
| Dose-limiting Toxicities (DLT) of Topical Compound 31543 | Compound 31543 Calcitriol - 10 μg/mL | 0 | Participants | ||
| Dose-limiting Toxicities (DLT) of Topical Compound 31543 | Compound 31543 Calcitriol - 20 μg/mL | 0 | Participants | ||
| Dose-limiting Toxicities (DLT) of Topical Compound 31543 | Compound 31543 Calcitriol - 40 μg/mL | 0 | Participants | ||
| Dose-limiting Toxicities (DLT) of Topical Compound 31543 | Compound 31543 Calcitriol - 60 μg/mL | 0 | Participants | ||
| Dose-limiting Toxicities (DLT) of Topical Compound 31543 | Compound 31543 Calcitriol - 80 μg/mL | 0 | Participants | ||
| Pre-dose Concentrations of Compound 31543 | Compound 31543 Calcitriol - 5 ug/mL | 49.0 | Standard Deviation 5.8 | pg/mL | |
| Pre-dose Concentrations of Compound 31543 | Compound 31543 Calcitriol - 10 ug/mL | 43.2 | Standard Deviation 14.8 | pg/mL | |
| Pre-dose Concentrations of Compound 31543 | Compound 31543 Calcitriol - 20 ug/mL | 54.3 | Standard Deviation 31.5 | pg/mL | |
| Pre-dose Concentrations of Compound 31543 | Compound 31543 Calcitriol - 40 ug/mL | 58.4 | Standard Deviation 19.4 | pg/mL |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Compound 31543 Calcitriol - 5 μg/mL | 3 | |
| Overall Study | STARTED | Compound 31543 Calcitriol - 10 μg/mL | 5 | |
| Overall Study | STARTED | Compound 31543 Calcitriol - 20 μg/mL | 6 | |
| Overall Study | STARTED | Compound 31543 Calcitriol - 40 μg/mL | 5 | |
| Overall Study | STARTED | Compound 31543 Calcitriol - 60 μg/mL | 6 | |
| Overall Study | STARTED | Compound 31543 Calcitriol - 80 μg/mL | 3 | |
| Overall Study | Treated | Compound 31543 Calcitriol - 5 μg/mL | 3 | |
| Overall Study | Treated | Compound 31543 Calcitriol - 10 μg/mL | 3 | |
| Overall Study | Treated | Compound 31543 Calcitriol - 20 μg/mL | 6 | |
| Overall Study | Treated | Compound 31543 Calcitriol - 40 μg/mL | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events288
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alopecia | Skin and subcutaneous tissue disorders | Compound 31543 Calcitriol - 5 μg/mL | 3 | 3 | 3 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Compound 31543 Calcitriol - 10 μg/mL | 3 | 3 | 3 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Compound 31543 Calcitriol - 20 μg/mL | 0 | 6 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Compound 31543 Calcitriol - 40 μg/mL | 2 | 4 | 2 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Compound 31543 Calcitriol - 60 μg/mL | 3 | 4 | 3 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Compound 31543 Calcitriol - 80 μg/mL | 3 | 3 | 3 |
| other | Rash Maculo-papular | Skin and subcutaneous tissue disorders | Compound 31543 Calcitriol - 5 μg/mL | 1 | 3 | 1 |
| other | Rash Maculo-papular | Skin and subcutaneous tissue disorders | Compound 31543 Calcitriol - 10 μg/mL | 1 | 3 | 1 |
| other | Rash Maculo-papular | Skin and subcutaneous tissue disorders | Compound 31543 Calcitriol - 20 μg/mL | 1 | 6 | 1 |
| other | Rash Maculo-papular | Skin and subcutaneous tissue disorders | Compound 31543 Calcitriol - 40 μg/mL | 0 | 4 | 0 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Compound 31543 Calcitriol - 5 μg/mL | 0 | 3 |
| Total, all-cause mortality | Compound 31543 Calcitriol - 10 μg/mL | 0 | 3 |
| Total, all-cause mortality | Compound 31543 Calcitriol - 20 μg/mL | 0 | 6 |
| Total, all-cause mortality | Compound 31543 Calcitriol - 40 μg/mL | 0 | 4 |
| Total, all-cause mortality | Compound 31543 Calcitriol - 60 μg/mL | 0 | 4 |
| Total, all-cause mortality | Compound 31543 Calcitriol - 80 μg/mL | 0 | 3 |
| Total, other adverse events | Compound 31543 Calcitriol - 5 μg/mL | 3 | 3 |
| Total, other adverse events | Compound 31543 Calcitriol - 10 μg/mL | 3 | 3 |
| Total, other adverse events | Compound 31543 Calcitriol - 20 μg/mL | 6 | 6 |
| Total, other adverse events | Compound 31543 Calcitriol - 40 μg/mL | 4 | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01588522
GET https://conductscience.org/api/trials/v1/NCT01588522/results?page=2