NCT03611985

Study of Pharmacokinetics and Safety of Epidiferphane™ and Taxanes in Breast Cancer Patients

Withdrawn Phase 1/Phase 2 Last updated 9 January 2020

What this trial tests

Phase 1/Phase 2 trial testing Epidiferphane in Breast Cancer. Withdrawn.

Timeline

1 March 2020

Primary endpoint
1 March 2023

1 March 2023

Quick facts

Lead sponsor	University of Florida
Phase	Phase 1/Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Design	sequential
Masking	none
Primary purpose	treatment
Start date	1 March 2020
Primary completion	1 March 2023
Estimated completion	1 March 2023

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.
• Rate of occurrence of DLTs by dose level in patients with breast cancer who are being treated with taxanes
  Time frame: 4 months
  This will be assessed by the rate of occurrence of DLTs by Epidiferphane dose level
• Maximum tolerated dose of Epidiferphane in patients with breast cancer who are being treated with taxanes
  Time frame: 3 months
• Cmax of taxanes
  Time frame: 3 weeks
  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.
• Number of adverse events (graded according to CTCAE v5.0 criteria) by epidiferphane dose level
  Time frame: 4 months
• 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.

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. Metabolic reprogramming in cancer and senescence.
   Zhang Y, Tang J, Jiang C, Yi H, et al · · 2025 · cited 13× · PMID 40046406 · DOI 10.1002/mco2.70055