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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 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.

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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.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Epidiferphane
  • DRUG Taxane Chemotherapy

Study Locations (1)

Florida

  • University of Florida - Gainesville

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2023-03-30
Est. Completion 2026-12
Phase Phase 1

Sponsor

University of Florida

1,106 total trials

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What the Registry Record Tells You About NCT05074290

The ClinicalTrials.gov registry entry for NCT05074290 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.