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NCT01588522 · ClinicalTrials.gov registry record · Phase 1
Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia
A Phase 1 study, sponsored by BPGbio.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01588522: Completed Phase 1 study, sponsored by BPGbio.
NCT01588522 is a Phase 1 study that has completed, run by BPGbio. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01588522, a Phase 1 study, has completed, sponsored by BPGbio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Compound 31543 Calcitriol 5 μg/mL
- DRUG Compound 31543 Calcitriol 10 μg/mL
- DRUG Compound 31543 Calcitriol 20 μg/mL
- DRUG Compound 31543 Calcitriol 40 μg/mL
- DRUG Compound 31543 Calcitriol 60 ug/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-09-17 |
| Est. Completion | 2017-02-16 |
| Phase | Phase 1 |
What the finished NCT01588522 record still lists
NCT01588522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 5 interventions - of which Compound 31543 Calcitriol 5 μg/mL is the first listed.
NCT01588522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01588522 about?
NCT01588522 is a clinical study titled "Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia". 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 problem...
What is the current status of trial NCT01588522?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2012-09-17. Estimated completion is 2017-02-16.
What interventions are being tested in trial NCT01588522?
The interventions under investigation include: Compound 31543 Calcitriol 5 μg/mL (DRUG), Compound 31543 Calcitriol 10 μg/mL (DRUG), Compound 31543 Calcitriol 20 μg/mL (DRUG), Compound 31543 Calcitriol 40 μg/mL (DRUG), Compound 31543 Calcitriol 60 ug/mL (DRUG).
Who is sponsoring clinical trial NCT01588522?
This trial is sponsored by BPGbio, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01588522's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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