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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 is a Phase 1 study that has completed, run by BPGbio. The registered enrollment target is 28 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01588522
The ClinicalTrials.gov registry entry for NCT01588522 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BPGbio, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Compound 31543 Calcitriol 5 μg/mL is the first listed.
NCT01588522 reports 0 study locations.
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.
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