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NCT05074290 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients
A Phase 1 study of Breast Cancer, sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT05074290: Recruiting Phase 1 study of Breast Cancer, sponsored by University of Florida.
NCT05074290 is a Phase 1 study of Breast Cancer that is actively recruiting participants, run by University of Florida. The registered enrollment target is 74 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05074290, a Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with breast cancer are commonly treated with taxane chemotherapy. Some very common side effects of taxanes, such as anemia and peripheral neuropathy, are often as not well addressed during treatment, resulting in dose reductions, dose delays and early discontinuation (collectively called relative dose intensity) of these chemotherapy agents in 15-80 % of patients on these drugs. This reduction in relative dose intensity (RDI) results in worse clinical outcomes such as progression free and overall survival. Pre-clinical studies in mouse models subjected to standardized chemotherapy regimens containing paclitaxel or oxaliplatin have shown that the nutritional supplement Epidiferphane reduces both neuropathy and anemia. This study will investigate whether the use of Epidiferphane in patients with breast cancer receiving taxane chemotherapy results in an attenuation of the side effects experienced, as well as an improvement in tumor response rate. The safety and maximum tolerated dose of Epidiferphane in this patient population will also be determined in this study.
Primary Outcome
The Cmax of each of Epidiferphane's components will be based on blood concentration measured prior to taxane chemotherapy administration, as well as at 1, 2 and 24 hours after taxane chemotherapy administration. The Cmax of each of Epidiferphane's components will be the blood concentration measured prior to taxane chemotherapy administration, as well as at 1, 2 and 24 hours after taxane chemotherapy administration.
Conditions Studied
Interventions
- DRUG Epidiferphane
- DRUG Taxane Chemotherapy
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2023-03-30 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT05074290 shows while recruiting
NCT05074290 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Epidiferphane is the first listed.
NCT05074290 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05074290 about?
NCT05074290 is a clinical study titled "Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients". Patients with breast cancer are commonly treated with taxane chemotherapy. Some very common side effects of taxanes, such as anemia and peripheral neuropathy, are often as not well addressed during treatment, resulting in dose reductions, dose delays and early discontinuation (collectively called re...
What is the current status of trial NCT05074290?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2023-03-30. Estimated completion is 2026-12.
What conditions does trial NCT05074290 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05074290?
The interventions under investigation include: Epidiferphane (DRUG), Taxane Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT05074290?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05074290 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05074290's enrollment target sits among peer trials
74 682nd of 1224 higher than 542 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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