NCT05074290

Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients

Recruiting now Phase 1/Phase 2 Last updated 16 February 2026

What this trial tests

Phase 1/Phase 2 trial testing Epidiferphane in Breast Cancer in 74 participants. Currently enrolling.

Timeline

30 March 2023

Primary endpoint
1 December 2026

1 December 2026

Quick facts

Lead sponsor	University of Florida
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	74
Start date	30 March 2023
Primary completion	1 December 2026
Estimated completion	1 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Epidiferphane — full drug profile →
• Taxane Chemotherapy — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

University of Florida

Who can join

Adults 18 to 99, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Cmax of Epidiferphane's components
  Time frame: 24 hours
  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 chemother
• Cmax of taxanes
  Time frame: 24 hours
  The Cmax of the taxane chemotherapy agents given will be based on blood concentrations measured prior to taxane chemotherapy administration, as well as at 1, 2 and 24 hours after taxane chemotherapy administration.
• Concentration at 24 hours (C24 hours) of Epidiferphane's components
  Time frame: 24 hours
  The C24 hours of each of Epidiferphane's components will be based on blood concentration measured 24 hours after taxane chemotherapy administration.
• Concentration at 24 hours (C24 hours) of taxanes
  Time frame: 24 hours
  The C24 hours of the taxanes given will be based on blood concentration measured 24 hours after taxane chemotherapy administration.
• Maximum tolerated dose of Epidiferphane in patients with breast cancer who are being treated with taxanes
  Time frame: 4 months
• Rate of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade 2 or higher neuropathy
  Time frame: 4 months

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The therapeutic potential of natural metabolites in targeting endocrine-independent HER-2-negative breast cancer.
   Püsküllüoğlu M, Michalak I. · · 2024 · cited 3× · PMID 38500769 · DOI 10.3389/fphar.2024.1349242